BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3961706 · Received July 28, 2014

    Report

    Report Number
    1823260-2014-05589
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE COMPACT PLUS SYSTEM. (B)(4). DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT SYSTEMS WITHIN 10 MINUTES: 17.0 MMOL/L (MOBILE SYSTEM) AND 7.0 MMOL/L (COMPACT PLUS SYSTEM). NO ACTIONS WERE TAKEN BASED ON THE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439323 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR NOVORAPID, 24.0 UNITS DAILY| LEVEMIR, 102.0 UNITS DAILY