BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 274056 · Received April 14, 2000

    Report

    Report Number
    2939301-2000-00281
    Event Type
    Malfunction
    Date Received
    April 14, 2000
    Report Date
    March 17, 2000
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPTR STATED THAT RPTR DID METER TO HCP METER COMPARISON TESTS, 10 MINS APART. RPTR STATED THAT RPTR'S NEW METER HAD A READING OF 377 MG/DL, AND THAT THE DR'S OFFICE METER (TYPE UNKNOWN) RESULT WAS 267 MG/DL. BOTH TESTS WERE CAPILLARY. NO SYMPTOMS WERE REPORTED. A CONTROL SOLUTION TEST WAS ABOVE RANGE 151 (100-150). 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 52 YR Other