Insulin Pump Software Glitchgreenspun.com : LUSENET : TimeBomb 2000 (Y2000) : One Thread
from: DIABETES FORECAST Magazine, Feb 00, page 53
MINIMED NOTIFIES PATIENTS OF ERROR
MiniMed Inc., manufacturer of insulin infusion pumps, announced that a software error could occur in its Model 508 insulin pump. The company described the error as "rare and minor" and has notified those who purchased the pump between October 4 and November 18. According to a MiniMed spokesperson, the software glitch affected the pump's basal rate feature.
Terrance H. Gregg, MiniMed's president and chief operating officer, asserted that the error was insignificant. "Our independent medical monitor confirmed for us that this anomaly does not represent an urgent matter. In addition to the patient notification, we will upgrade the software in the affected pumps early next year." (note: Presumably, this article was written before the rollover.)
All products shipped since this announcement contain an upgraded version of the software.
Note: Y2K is not mentioned in this notice. However, this is the first diabetes-software-related problem I've heard of since such software first began to be written.
-- Norm Harrold (firstname.lastname@example.org), January 24, 2000
Do you have a link, or any more information. This is VERY important to me, since my daughter wears this model of pump.
If you don't want to post, please e-mail (my e-mail is real).
-- No Polly (email@example.com), January 24, 2000.
I didn't find ANY mention of the abovementioned software defect on the MiniMed site!
MiniMed Inc. Announces Patient Notification
Sylmar, California, November 19, 1999 -- MiniMed Inc. (Nasdaq: MNMD) announced today that it is initiating a patient notification procedure relating to a rare and minor software error which could occur in certain of its Model 508 insulin infusion pumps distributed since October 1999. MiniMed reported that this situation may be created by a very specific programming sequence that some users may possibly follow. The company stated that the issue has been addressed, and all products shipped beginning today contain an upgraded version of the software.
Alfred E. Mann, MiniMed's Chairman and CEO, stated, "This situation was identified quickly as a result of the strict performance monitoring which we conduct on all of our products. A notification containing programming instructions which will eliminate this potential occurrence has been sent to those pump users who purchased Model 508 pumps from October 4 through November 18. We believe that the MiniMed 508 offers the state of the art in safety, reliability and clinical benefit for patients who treat their diabetes with continuous insulin infusion."
Terrance H. Gregg, MiniMed's President and Chief Operating Officer, added, "Our independent medical monitor confirmed for us that this anomaly does not represent an urgent matter. In addition to the patient notification, we will upgrade the software in the affected pumps early next year. Our estimated cost for this activity is expected to range between $1 million and $1.5 million."
MiniMed Inc. designs, develops, manufactures and markets advanced infusion systems with a primary emphasis on the intensive management of diabetes. The Company's products include external pumps and related disposables, a continuous glucose monitoring system product and the distribution of an implantable insulin pump, which is currently approved for sale in the European Community and has not yet been cleared for marketing in the U.S. The Company also distributes other diabetes supplies and pharmaceutical products.
Any statements made by MiniMed in this press release that are forward- looking, including statements relating to the costs associated with upgrading the software in affected pumps, are made pursuant to the Safe Harbor provisions of the Private Securities Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect MiniMed's business and prospects, including changes in economic and market conditions, the number of MiniMed employees or outside consultants available to upgrade the affected pumps, administration and regulatory approval and related considerations and other factors discussed in the Company's filings with the Securities and Exchange Commission.
For: MiniMed Inc. (818) 362-5958 Terrance H. Gregg President and Chief Operating Officer
Kevin R. Sayer Senior Vice President and Chief Financial Officer
Morgen-Walke Associates Investor Relations: Robert P. Jones/Ephraim R. Bernstein: (212) 850-5600
Media: Sheryl Seapy: (415) 296-7383
-- (firstname.lastname@example.org), January 25, 2000.
NoPolly: The article I copied from DIABETES FORECAST isn't available on the magazine's website (http://www.diabetes.org/diabetesforecast/); but I'm forwarding a separate response to my posting, in case you haven't already read it above. Note the somewhat hypocritical statement by MiniMed that they found the problem "quickly, as a result of their strict performance monitoring"....but here it is, several months and $1.5 million later, and they are just now getting the problem resolved. Typical, I guess. I get the impression that perhaps they didn't find this problem until complaints started coming in from users (i.e., "performance monitors"?); but I may be wrong....who knows?
-- Norm Harrold (email@example.com), January 25, 2000.
Note the somewhat hypocritical statement by MiniMed that they found the problem "quickly, as a result of their strict performance monitoring"....but here it is, several months and $1.5 million later, and they are just now getting the problem resolved.
Actually, they sent instructions on how to avoid this problem as soon as they discovered it back in November and also fixed the problem in all new shipping pumps at the same time. What takes longer is arranging to upgrade the software in the affected pumps, most likely because you can't simply send back an insulin pump unless you have a spare, or are willing and able to go back to injections. Since the error does indeed appear to be "rare and minor," it is far more convenient for the pump user to continue to use the pump while MiniMed figures out how it's going to distribute the upgrade.
-- (firstname.lastname@example.org), January 25, 2000.