BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 313218 · Received January 18, 2001

    Report

    Report Number
    2939301-2001-00062
    Event Type
    Malfunction
    Date Received
    January 18, 2001
    Report Date
    December 21, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT BACK TO BACK TESTS PERFORMED ON THE SURESTEP METER USING SEPARATE FINGER STICKS WERE 297, 175 AND 109 MG/DL. NO SYMPTOMS WERE REPORTED. CONTROL SOLUTION TEST RESULTS (131, 135) WERE IN RANGE (97-142). UNABLE TO REACH PT ON FOLLOW-UP. LETTER SENT TO PT REQUESTING THE PT TO CONTACT LFS. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456 SURESTEP BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other