BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1852489 · Received October 4, 2010

    Report

    Report Number
    1823260-2010-05869
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 26, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE AVIVA SYSTEM. REFERENCE MEDWATCH REPORT WITH (B)(6) THE ADVANTAGE SYSTEM.

    Description of Event or Problem · 1

    ASR REVISION RECOMMENDED - LEFT HIP.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 12 MG/DL (ADVANTAGE) AND 120 MG/DL (AVIVA) 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 ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 301974

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR CATAPRIL 1X DAILY| LANTUS INSULIN| HUMULOG INSULIN 3X DAILY| VITAMIN