BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2182384 · Received July 28, 2011

    Report

    Report Number
    1823260-2011-04052
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 21, 2011
    Report Date
    September 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR THE COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 2.6 MMOL/L ON THE AVIVA SYSTEM AND RESULT OF 6.1 MMOL/L ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    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 490076

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR NOVORAPID IN THE MORNING