BEUDAMED
    FDA Adverse Event Other Summary report: N

    FASTTAKE

    MDR report key: 378393 · Received February 1, 2002

    Report

    Report Number
    2939301-2002-01393
    Event Type
    Other
    Date Received
    February 1, 2002
    Report Date
    November 12, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: FAST TAKE. STRIP NAME: FAST TAKE. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: LOW-THUMB FINGERS/LIPS. A PT REPORTED THEY WERE NOT ABLE TO GETTING A READING. HAD TO GO TO HOSP TO BE TESTED. THEIR METER ALLEGEDLY HAS MISSING SEGMENTS. THE RESULT ON THEIR METER WAS: RESULT IS UNKNOWN. THE RESULT ON THE HOSP METER WAS 87. THE TIME DIFFERENCE BETWEEN PT'S METER AND: NO COMPARISON. TREATMENT WAS: ORANGE JUICE. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization