BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 212686 · Received February 26, 1999

    Report

    Report Number
    2939301-1999-00096
    Event Type
    Malfunction
    Date Received
    February 26, 1999
    Report Date
    February 3, 1999
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATED THAT IN A METER TO HEALTHCARE PROFESSIONAL METER TEST COMPARISON, THE BLOOD GLUCOSE RESULTS WERE 118 AND 188 MG/DL, RESPECTIVELY, USING THE SAME FINGERSTICK. RPTR THEN STUCK A SECOND FINGER AND GOT RESULTS OF 147 AND 126 ML/DL, BOTH WITH HIS METER. CONTROL SOLUTION TEST WAS 113(1880131) ML/DL. RPTR ADDED THAT HE OFTEN CANNOT GET ENOUGH BLOOD AND WILL ADD A SECOND DROP TO THE TESTSTRIP. DURING CONTACT WITH LIFESCAN RPTR PERFORMED TWO MORE, BACK-TO-BACK FINGERSTICKS, USING DIFFERENT FINGERS, RESULTING IN BLOOD GLUCOSE READINGS OF 99 AND 134 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other