BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER 3 WITH MEMORY

    MDR report key: 86666 · Received April 21, 1997

    Report

    Report Number
    1810909-1997-00004
    Event Type
    Malfunction
    Date Received
    April 21, 1997
    Date of Event
    March 11, 1997
    Report Date
    April 21, 1997
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS THE DAUGHTER OF A DIABETIC. SHE STATES THAT HER MOTHER'S BLOOD GLUCOSE READINGS HAVE BEEN LOWER WHEN COMPLAINED TO A COMPETITIVE METHOD. FOR EXAMPLE, THE METER WITH MEMORY WAS GIVING READINGS IN THE MID 30'S TO 40 MG/DL, WHILE HER PHYSICIAN'S METER WAS GIVING RESULTS OF 300 AND 256 MG/DL. THE TIME DIFFERENCES BETWEEN READINGS IS UNK. CHECK PADDLE RESULTS WERE SATISFACTORY. THE CUSTOMER DID NOT HAVE THE NORMAL CONTROL TESTING. ADDITIONAL REAGENT STRIPS AND THE NORMAL CONTROL SOLUTION WAS SENT TO THE CUSTOMER. CONTROL TESTING WAS SATISFACTORY. A REQUEST WAS MADE TO RETURN THE ORIGINAL REAGENT STRIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER 3 WITH MEMORY BLOOD GLUCOSE METER CFR BAYER CORP. 5485M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN