BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 1933906 · Received December 21, 2010

    Report

    Report Number
    1823260-2010-07586
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 16, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACTIVE S SYSTEM WITHIN 10 MINUTES: 279 MG/DL AND 120 MG/DL; 235 MG/DL AND 116 MG/DL. THE COMPARISONS WERE PERFORMED ON THE SAME DATE, 6 HOURS APART. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 23421636

    Patients

    Seq Age Sex Outcome Treatment
    1 089 YR LANTUS INSULIN