BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 235333 · Received August 6, 1999

    Report

    Report Number
    2939301-1999-00602
    Event Type
    Malfunction
    Date Received
    August 6, 1999
    Report Date
    July 9, 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

    Additional Manufacturer Narrative · 1

    METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8

    Description of Event or Problem · 1

    THE REPORTER STATED THAT HE DID BACK TO BACK BLOOD GLUCOSE TESTS USING SEPARATE FINGER STICKS. THE TESTS WERE DONE WITHIN 4 MINUTES WITH RESULTS OF 161, 175 AND 205 MG/DL. THE REPORTER DID NOT HAVE ANY SYMPTOMS. DUE TO UNAVAILABILITY OF SUPPLIES CONTROL SOLUTION TESTING WAS NOT DONE. NO HARM 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 67 YR Other