BEUDAMED
    FDA Adverse Event Death Summary report: N

    FASTTAKE

    MDR report key: 364252 · Received November 28, 2001

    Report

    Report Number
    2939301-2001-01103
    Event Type
    Death
    Date Received
    November 28, 2001
    Date of Event
    February 22, 2000
    Report Date
    October 6, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT A FASTTAKE METER MIGHT HAVE CONTRIBUTED TO THE PT'S DEATH. PT WAS ON A RENAL DIALYSIS AT TIME OF EVENT. PT PURCHASED THE FT METER 6 WEEKS BEFORE PT'S DEATH. IN 2001, PT'S BLOOD GLUCOSE WAS 88MG/DL BEFORE GOING TO BED. PT DIED AT 03:00AM THE NEXT DAY. CAUSE OF DEATH AS STATED IN THE DEATH CERTIFICATE WAS NEPHRITIS AND COMPLICATIONS OF DIABETES. CONSUMER SAW PT THE NEXT DAY, AND THE PT DID NOT LOOK GOOD, BUT NOT LIKE THE PT WAS GOING TO DIE." CONSUMER ADDED THAT THE CONSUMER IS A TRAINED EMT AND "KNOWS WHAT A PERSON LOOKS LIKE BEFORE THEY DIE." NO FURTHER INFO HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53519 FASTTAKE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death INSULIN SLIDING SCALE, 15 OTHER UNK MEDICATIONS.