BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1981912 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00704
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 263 MG/DL, 129 MG/DL AND 181 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. 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 STRIPS WERE ALL USED, 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 303020

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR HYDROCHLOROTHIAZIDE| MULTIVITAMIN (3 TIMES WEEKLY)| ACTOS| LISINOPRIL| ASPIRIN| METFORMIN| CRESTOR