BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 276742 · Received May 3, 2000

    Report

    Report Number
    2939301-2000-00364
    Event Type
    Malfunction
    Date Received
    May 3, 2000
    Report Date
    April 5, 2000
    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

    THE RPTR STATED THAT RPTR DID METER TO METER COMPARIS0N TESTS. RPTR'S METER READING WAS 200 MG/DL, AND THE DEX METER READ 86 MG/DL. SPECIFIC INFO ON THE TESTING WAS NOT GIVEN. RPTR DID NOT HAVE ANY SYMPTOMS. CONTROL TESTING RESULTS WERE IN RANGE, 141, 140, 132 (105-158). NO HARM WAS ALLEGED. ATTEMPTS TO REACH THE RPTR FOR FURTHER INFO HAVE NOT BEEN SUCCESSFUL.

    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 UNKNOWN Other