BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2770016 · Received October 3, 2012

    Report

    Report Number
    1823260-2012-04929
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 420 MG/DL, 187 MG/DL, AND 145 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490984

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR MIRTAZAPINE 1X DAILY| TRAVATAN Z 1X DAILY| BENAZEPRIL 1X DAILY| ALPHAGAN P 1X DAILY| FUROSEMIDE 1X DAILY| OMEPRAZOLE 1X DAILY| CARVEDILOL 2X DAILY| AMLODIPINE| NOVOLOG FLEX PEN| LANTUS SOLOSTAR