BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 242094 · Received September 24, 1999

    Report

    Report Number
    2939301-1999-00744
    Event Type
    Malfunction
    Date Received
    September 24, 1999
    Report Date
    August 26, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    RPTR DID BACK TO BACK BLOOD GLUCOSE TESTING AND GOT RESULTS OF 56, 64 AND 109 MG/DL. TESTS WERE DONE WITHIN 10 MINS, USING DIFFERENT FINGERSTICKS. NO SYMPTOMS WERE REPORTED. ON FOLLOW-UP, RPTR STATED THAT SHE COULD TELL WHEN HER RESULTS WERE NOT CORRECT BECAUSE THE BLOOD WOULD NOT ABSORB INTO THE STRIP, BUT WOULD SPREAD ACROSS THE TOP OF THE WHITE PAD. WHEN THIS HAPPENED, THERE WERE WHITE STREAKS ON THE CONFIRMATION DOT. SHE WOULD THEN RETEST. ALL TESTS WERE DONE FROM THE SAME LOT OF STRIPS. RPTR DID NOT DO A CONTROL SOLUTION TEST DUE TO LACK OF SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CGA LIFESCAN, INC. NA C904703A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other