BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 288011 · Received July 25, 2000

    Report

    Report Number
    2939301-2000-00602
    Event Type
    Malfunction
    Date Received
    July 25, 2000
    Report Date
    June 28, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR DID BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TESTS. PT'S RESULTS WERE 142, 182, 169 AND 177 MG/DL. PT DID NOT HAVE ANY SYPTOMS. IRREGULAR TEST STRIP REACTION NOTED. CONTROL TESTING WAS NOT DONE DUE TO LACK OF SUPPLIES. ON FOLLOW-UP, THE RPTR STATED A FEW STRIPS FROM THE LOT WOULD NOT REACT. UNUSED STRIP WOULD BE WHITE, BUT AFTER BLOOD WAS APPLIED, HAD A WHITE LINE THROUGH LENGTH OF THE CONFIRMATION DOT. REPORTEDLY HAS A GOOD SAMPLE. HAS BEEN CLEANING METER WITH ALCOHOL. USING NEW STRIPS. PT HAS NOT HAD AN ISSUE. NO HARM WAS ALLEGED.

    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