BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® AVIVA TEST STRIPS

    MDR report key: 1812979 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05034
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE AVIVA SYSTEM. (B)(4). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE AVIVA SYSTEM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 1) 183 MG/DL (ADVANTAGE) AND 93 MG/DL (AVIVA) 2) 176 MG/DL (ADVANTAGE) AND 81 MG/DL (AVIVA) SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF THE BROACH BROKE OFF IN THE FEMORAL CANAL AND WAS LEFT IN THE PATIENT.

    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 302647

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR GLIPIZIDE 2X DAILY