BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1860216 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-05933
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 560 MG/DL (B)(4) AND 220 MG/DL (B)(4) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, CUSTOMER HAS DISCARDED STRIPS THAT GAVE ERRANT RESULTS. REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT RECEIVED FROM THE (B)(6) TO BAXTER (B)(4). REPORTEDLY, ON UNSPECIFIED DATE, THE PATIENT (B)(6) HAS CONNECTION ISSUES WITH (B)(4) HOMECHOICE AUTO PDSET 8-PRONG CASSETTE ((B)(4)). DURING THE PRIMING PHASE, THE LIQUID BEGINS TO PASS THROUGH THE LINE, IT IS DISCONNECTED FROM THE BAG AND THE LIQUID LEAK ON THE FLOOR. SAMPLE NOT AVAILABLE. THIS IS REPORT 1 OF 3.

    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 302855

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR RAZAPAN 4X DAILY| LEVEMIR| NOVOLOG| CYCLOPRAN| MORPHINE SULPHATE| WARFARIN