BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1930614 · Received December 16, 2010

    Report

    Report Number
    1823260-2010-07511
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 8, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 302026, EXPIRATION DATE 12/31/2010). CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 56 MG/DL AND 54 MG/DL ON AVIVA SYSTEM 1 AND 95 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. 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 302026

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR NEXIUM| LABETALOL| FELODIPINE| "HUMULIN"| ALLOPURINOL| FUROSEMIDE| PAROXETINE| JANUVIA