BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1842708 · Received September 23, 2010

    Report

    Report Number
    1823260-2010-05645
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 14, 2010
    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

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 293 MG/DL AND 101 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. REPORTER DID SAY THAT SHE HAD NOT WASHED HANDS PRIOR TO TESTING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 302312

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR APNEA MONITOR| METFORMIN| PRAVASTATIN SODIUM| LEVOXYL