BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 238108 · Received August 27, 1999

    Report

    Report Number
    2939301-1999-00673
    Event Type
    Malfunction
    Date Received
    August 27, 1999
    Report Date
    July 30, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE RPTR PERFORMED A BLOOD GLUCOSE TEST ON HIS SURESTEP METER AND GOT A RESULT OF 96 MG/DL. HE THEN TESTED ON HIS ELITE METER AND GOT A RESULT OF 122 MG/DL. HE USED THE SAME FINGERSTICK FOR BOTH TESTS. RPTR PERFORMED ANOTHER TEST ON HIS SURESTEP AND GOT RESULTS OF 126 AND 118 MG/DL. HE WAS NOT SURE WHETHER HE USED THE SAME FINGERSTICK OR NOT. HIS CONTROL SOLUTION TEST WAS WITHIN RANGE 127. RPTR RAN MORE TESTS AND GOT RESULTS OF 138, 128 AND 143 MG/DL ON SURESTEP AND 141, 139 AND 137 MG/DL ON ELITE. CONTROL SOLUTION TEST RESULT WAS WITHIN RANGE 128 (98-147).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other