BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 534189 · Received March 12, 2004

    Report

    Report Number
    2939301-2004-01680
    Event Type
    Malfunction
    Date Received
    March 12, 2004
    Report Date
    March 10, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED BLOOD GLUCOSE RESULTS OF 57 MG/DL WITH A LIFESCAN METER AND 89 MG/DL ON A LAB DEVICE FOR THE FIRST PT, 120 MG/DL WITH LIFESCAN METER AND 74 MG/DL ON A LAB DEVICE WITH THE 2ND PT; 154 MG/DL WITH LIFESCAN METER AND 96 MG/DL ON A LAB DEVICE WITH THE 3RD PT; AND 260 MG/DL WITH LIFESCAN METER AND 183 MG/DL ON A LAB DEVICE WITH THE 4TH PT PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTTAKE GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 1020172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN