BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 628015 · Received August 9, 2005

    Report

    Report Number
    2939301-2005-03480
    Event Type
    Malfunction
    Date Received
    August 9, 2005
    Report Date
    August 1, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CALLED LIFESCAN (LFS) AND IN 08/2005 AND ALLEGED THAT THEIR METER WAS PROMPTING A NOT OK MESSAGE. MEDICAL AFFAIRS ATTEMPTED UNSUCCESSFULLY TO SPEAK TO THE PATIENT FOR MORE CLINICAL INFORMATION. A LETTER HAS BEEN SENT AS A SECOND ATTEMPT. THE PATIENT WAS OBTAINING A NOT OK MESSAGE WHILE ATTEMPTING TO TEST. THEY WENT TO THE EMERGENCY ROOM AND THEIR BLOOD GLUCOSE RESULT ON THE HOSPITAL METER WAS 600MG/DL. PATIENT WAS TREATED WITH 30 UNITS OF NOVOLIN INSULIN AND AN IV. THE PATIENT REPORTED EXPERIENCING CHEST PAIN. IT IS NOT KNOWN HOW LONG THE PATIENT WAS EXPERIENCING THE ISSUE WITH THE METER, NOR IS THE PATIENT'S MEDICATION REGIMEN. THE METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. A REPLACEMENT METER HAS BEEN SENT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO EVIDENCE OF THE METER CONTRIBUTING TO A SERIOUS INJURY BECAUSE CO DOES NOT KNOW HOW LONG THE PATIENT WAS UNABLE TO TEST ON THEIR METER OR THE PATIENT'S MEDICATION REGIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 257319B

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR