BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 251919 · Received November 24, 1999

    Report

    Report Number
    2939301-1999-01007
    Event Type
    Malfunction
    Date Received
    November 24, 1999
    Report Date
    October 29, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A METER TO LAB METER COMPARISON TEST WAS MADE WITH THE REPORTER'S METER READING 114 MG/DL AND THE LAB METER (SAME TYPE) 160 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES. THERE WERE NO SYMPTOMS. A CONTROL SOLUTION TEST WAS WITHIN RANGE 131 (100-150). UNABLE TO REACH REPORTER FOR A FOLLOW-UP SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CGA LIFESCAN, INC. NA B943898A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other