BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 238022 · Received August 25, 1999

    Report

    Report Number
    2939301-1999-00656
    Event Type
    Malfunction
    Date Received
    August 25, 1999
    Report Date
    July 26, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RPTR STATED THAT HE DID A METER TO LAB COMPARISON TEST AT DR'S OFFICE. TESTING WAS DONE SIDE BY SIDE. HIS CAPILLARY METER TEST WAS 85 MG/DL, AND VENOUS LAB RESULT WAS 121 MG/DL. HE DID NOT HAVE ANY SYMPTOMS. DURING TROUBLE SHOOTING, A CONTROL SOLUTION (OPENED 2/99) TEST RESULT WAS 153 (103-155). USING NEW TEST STRIPS, A 2ND CONTROL TEST WAS 128. RPTR STATED THAT HE ONLY TESTS AM FASTING, EVERY 2 OR 3 DAYS, AND TAKES ONE AMARYL TABLET EACH AM. HE HAD NEVER CLEANED HIS METER. LIFESCAN REP DID TRAINING WITH THE RPTR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other