BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2011899 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01278
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 28, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    CALLER STATES CUSTOMER TESTED 46 MG/DL (12:50) AND 38 MG/DL (12:57) ON THE AVIVA SYSTEM. CALLER TREATED THE CUSTOMER WITH BREAD AND JELLY AND CUSTOMER TESTED 310 MG/DL (13:02) AND 142 MG/DL (13:04). 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 ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 303166

    Patients

    Seq Age Sex Outcome Treatment
    1 003 YR LANTUS| NOVOLOG