BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 431234 · Received December 4, 2002

    Report

    Report Number
    2939301-2002-11610
    Event Type
    Injury
    Date Received
    December 4, 2002
    Date of Event
    November 20, 2002
    Report Date
    November 27, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT TESTED AND OBTAINED A 237MG/DL; PT THEN TOOK 12UNITS OF INSULIN. TWO HOURS LATER PT TESTED AGAIN AND OBTAINED A 157 MG/DL. PT RETESTED AGAIN 15 MINUTES LATER WITH A NEW VIAL OF TEST STRIPS AND OBTAINED A 45MG/DL. PT THEN TREATED THEMSELVES WITH 5 AND ONE HALF UNITS OF CARBOHYDRATES. PT DID NOT SEEK ANY MEDICAL ATTENTION OR CALL THEIR MD. UNCLEAR IF PT EXPERIENCED ANY SYMPTOMS. SUBJECT LOT # OF TEST STRIPS 1019248 WAS FALLING OUT OF RANGE WITH THE CONTROL SOLUTION. RANGE WAS (100-135) AND RESULT WAS 216. LIFESCAN REP FOUND OUT THAT CONTROL SOLUTION WAS OPENED FOR MORE THAN THREE MONTHS. LFS REP SENT PT A NEW VIAL OF CONTROL SOLUTION AND ASKED PT TO SEND BACK SUBJECT LOT #1019248 OF TEST STRIPS. LIFESCAN RECEIVED THE SUBJECT LOT # OF TEST STRIPS AND DID A CONTROL SOL TEST LOT # 1A2C07 AND OBTAINED A READING OF 197, 206 AND 201, RANGE IS (100-135). PT HAS NOT RECEIVED NEW VIAL OF CONTROL SOLUTION YET, BUT WHEN THEY DO, THEY WILL CALL LIFESCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA 1019248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN