BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1904578 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06922
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    May 24, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 383 MG/DL AND 108 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER ALSO ALLEGED OBTAINING THE RESULTS OF 241 MG/DL AND 114 MG/DL ON THE SAME AVIVA SYSTEM WITHIN 10 MINUTES, BUT ON A SEPARATE DAY. REPORTER ALSO ALLEGED OBTAINING THE RESULTS OF 310 MG/DL AND 98 MG/DL ON THE SAME AVIVA SYSTEM WITHIN 10 MINUTES, BUT ON A SEPARATE DAY. REPORTER ALSO ALLEGED OBTAINING THE RESULTS OF 267 MG/DL AND 128 MG/DL ON THE SAME AVIVA SYSTEM WITHIN 10 MINUTES, BUT ON A SEPARATE DAY. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THE SHE NO LONGER HAS THE STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR BENAZEPRIL| NEBULIZER| METFORMIN| VICTOZA