BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® ACTIVE TEST STRIPS

    MDR report key: 1980996 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00681
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACTIVE S SYSTEM WITHIN 10 MINUTES: 51 MG/DL AND 100 MG/DL. 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 23416131

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR GLYPIZIDE 2X DAILY