BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1823757 · Received September 2, 2010

    Report

    Report Number
    1823260-2010-05220
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 15, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 361 MG/DL AND 116 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT COULD NOT FEEL ANY VNS STIMULATION, AND THAT A CONSULT WITH AN ENT SPECIALIST REVEALED THERE WAS NO VOCAL CORD MOVEMENT WITH VNS STIMULATION, WHICH WAS NOT AN EXPECTED EVENT. THERE WERE NO ISSUES WITH THE VOCAL CORDS THEMSELVES. THE PATIENT WAS RECENTLY IMPLANTED WITH THE VNS, AND HAS NEVER FELT ANY STIMULATION, EVEN WHEN THE STIMULATION WAS INCREASED. VNS DIAGNOSTICS RESULTS INDICATE NORMAL DEVICE FUNCTION. IT IS FELT BY THE REPORTER THE VNS ELECTRODES ARE LIKELY NOT ON THE VAGUS NERVE. THE VNS HAS BEEN DISABLED. X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. NO LEAD ANOMALIES WERE VISUALIZED THAT MAY BE CONTRIBUTING TO THE PATIENT NOT FEELING ANY STIMULATION; HOWEVER, IT CANNOT BE DETERMINED BY X-RAY REVIEW ALONE IF THE ELECTRODES ARE ON THE VAGUS NERVE. SURGICAL INTERVENTION TO EXPLORE THE VNS LEAD AREA IS PLANNED, BUT A SURGERY DATE HAS NOT BEEN SET.

    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 302513

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR LOW DOSE ASPIRIN| GLYBURIDE| CADUET| CLONIDINE| FUROSEMIDE| LISINOPRIL| CILOSTAZOL