BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 241477 · Received September 16, 1999

    Report

    Report Number
    2939301-1999-00762
    Event Type
    Malfunction
    Date Received
    September 16, 1999
    Report Date
    August 17, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8

    Description of Event or Problem · 1

    THE REPORTER DID BACK TO BACK BLOOD GLUCOSE TESTS OVER A 3-DAY PERIOD. RESULTS ON 1ST DAY WERE 102, 152, 124; 2ND DAY - 130, 153, 119 AND 167 MG/DL; AND 3RD DAY - 167, 136 AND 142 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES, USING ONE FINGERSTICK. HE DID NOT HAVE ANY SYMPTOMS. DURING FOLLOW-UP, IT WAS DETERMINED THAT THE REPORTER WAS STORING HIS TEST STRIPS ON TOP OF HIS REFRIGERATOR (WHERE IT IS QUITE WARM). REPORTER HAD USED THESE TEST STRIPS TO DO CONTROL SOLUTION TESTS ON THE OLD AND NEW METER, AND BOTH METERS GOT ER2 MESSAGE RESULTS.

    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 61 YR Other