BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2233325 · Received September 2, 2011

    Report

    Report Number
    1823260-2011-04720
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 29, 2011
    Report Date
    September 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON A ROCHE METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 157 MG/DL (AVIVA) AND 45 MG/DL (LAB) CUSTOMER WAS FASTING AT THE TIME OF THE READINGS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, CUSTOMER STATES THAT THE STRIPS HAVE BEEN THROWN AWAY. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR NOVOLOG| LEVEMIR| LASIX| WHEELCHAIR