BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2214122 · Received August 17, 2011

    Report

    Report Number
    1823260-2011-04383
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE AVIVA SYSTEM 1. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE AVIVA SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 197 MG/DL (AVIVA SYSTEM AND, 97 MG/DL (AVIVA SYSTEM, NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, STRIPS HAVE BEEN CONSUMED. 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
    1 075 YR BABY ASPIRIN| METOPROLOL| PRAVASTATIN| BLOOD PRESSURE MONITOR| NOVOLIN 70/30| LISINOPRIL