BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 212945 · Received March 2, 1999

    Report

    Report Number
    2939301-1999-00105
    Event Type
    Malfunction
    Date Received
    March 2, 1999
    Report Date
    February 5, 1999
    Manufacturer
    LIFESCAN INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR DID A METER-TO-HEALTH CARE PROFESSIONAL TEST WITH BLOOD GLUCOSE RESULTS OF 199 AND 270 MG/DL RESPECTIVELY. RPTR ALSO STATED SHE GOT THREE ERL MESSAGES BUT HAD NOT APPLIED ENOUGH BLOOD TO TESTSTRIP OR HAD APPLIED SAMPLE TO WRONG SIDE TO TESTSTRIP. RPTR WAS USING OFF-BRAND TESTSTRIPS AND HER PREVIOUS THREE RESULTS WERE 148, 172 AND 281 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD BLUCOSE METER CGA LIFESCAN INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other