BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1780628 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08447
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 3, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT AVIVA BLOOD GLUCOSE TEST STRIPS, LOT # 300108, CATALOG # 04588028001, WERE LABELED WITH AN EXPIRATION DATE OF 10/28/2007. A BATCH RECORD REVIEW BY THE (B)(4) MANUFACTURING SITE FOUND THAT THE CATALOG # DOES NOT EXIST, AND THAT THERE HAS NEVER BEEN A BATCH OF AVIVA STRIPS WITH THE REPORTED LOT #. IN ADDITION, ALL AVIVA TEST STRIPS HAVE EXPIRATION DATES THAT COINCIDE WITH THE LAST DAY OF THE MONTH, WHICH IS INCONSISTENT WITH THE REPORTED DATE. IT IS NOTED THAT THE REPORTER DISCONNECTED THE CALL BEFORE MORE INFORMATION COULD BE GATHERED. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. RETURN OF THE SUSPECT PRODUCT WAS REQUESTED; REPLACEMENT PRODUCT 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 LFR ROCHE DIAGNOSTICS 300108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK