BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1951323 · Received January 6, 2011

    Report

    Report Number
    1823260-2011-00082
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 20, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 431 MG/DL ON THE AVIVA SYSTEM AND 120 MG/DL ON PROFESSIONAL DEVICE WITHIN 10 MINUTES. CUSTOMER STATES SHE WAS VOMITING WITH RESULT OF 431 MG/DL; NO MEDICAL TREATMENT RECEIVED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 302911

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR NOVOLIN N| STENTS IN ABDOMEN| HUMULIN R