BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2021871 · Received March 17, 2011

    Report

    Report Number
    1823260-2011-01443
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN GERMANY. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA NANO SYSTEM (LOT NUMBER 202445, EXPIRATION DATE 06/30/2011). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE AVIVA COMBO SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA COMBO SYSTEM WITHIN 10 MINUTES: HI (GREATER THEN 600 MG/DL), 13 MG/DL, AND 158 MG/DL. A RESULT OF 123 MG WAS ALSO OBTAINED ON THE CUSTOMER'S AVIVA NANO SYSTEM WITHIN 10 MINUTES OF THE RESULTS OBTAINED FROM THE AVIVA COMBO. 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 NA 202445

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR HUMALOG