BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2395543 · Received January 3, 2012

    Report

    Report Number
    1823260-2012-00037
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 20, 2011
    Report Date
    January 3, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 586 MG/DL, 268 MG/DL, AND 196 MG/DL. 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 303331

    Patients

    Seq Age Sex Outcome Treatment
    1 ECOTRIN ONCE DAILY| JANUVIA| VITAMIN C TWICE DAILY| MULTIVITAMINS| COLACE| OMEPRAZOLE MAGNESIUM| ACETAMINOPHEN PM DAILY| ACETAMINOPHEN| ACCUPRIL TWICE DAILY| PLAVIX ONCE DAILY| NORVASC ONCE DAILY| HUMALOG 75/25| IMDUR ONCE DAILY