BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 713080 · Received November 18, 2005

    Report

    Report Number
    2939301-2005-05288
    Event Type
    Malfunction
    Date Received
    November 18, 2005
    Date of Event
    November 7, 2005
    Report Date
    November 7, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 11/7/05, THE LAY PATIENT CONTACED LIFESCAN ALLEGING THAT HIS FAST TAKE METER WAS READING INACCURATELY ERRATIC. ON 11/7/05 HE OBTAINED RESULT OF 223, 179, AND 128 MG/DL ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER. HE DID NOT RECEIVE TREATMENT AT THE TIME OF CONCERN. THE PATIENT SAID THAT HE HAD CONTACTED HIS DOCTOR ON ANOTHER OCCASION WHEN HE OBTAINED ERRATIAC READINGS AND WAS TOLD TO START INJECTING BYETTA; THE BLOOD GLUCOSE READINGS OBTAINED AT THAT TIME WERE NOT PROVIDED. A CONTROL SOLUTION TEST WAS NOT PERFORMED, AS THE CONTROL SOLUTION WAS EXPIRED. THE METER AND TEST STRIPS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTTAKE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2526764

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR