BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2032252 · Received March 29, 2011

    Report

    Report Number
    1823260-2011-01663
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 16 MG/DL, 100 MG/DL, AND 191 MG/DL. CUSTOMER REPORTED FEELING "FUNKY;" SHE STATES SHE WAS THIRSTY AND HUNGRY WHEN THE REPORTED RESULTS WERE OBTAINED. CUSTOMER CONSUMED FOOD ON HER OWN AND SYMPTOMS SUBSIDED IN 30 MINUTES. 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 303078

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR NORVASC| "OXYCODONE"| OXYCONTIN| PREVACID