BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3913630 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04898
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM (LOT NUMBER AND EXPIRATION DATE UNKNOWN). (B)(4). DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULTS OF 32 MMOL/L (0830) AND 19 MMOL/L (0834) ON THE MOBILE SYSTEM. CUSTOMER THEN TESTED 6.2 MMOL/L (0834) ON THE COMPACT PLUS SYSTEM AND 26 MMOL/L (0844) ON THE MOBILE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER THE CUSTOMER NO LONGER HAS THE TEST CASSETTE; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391079 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR NOVORAPID| LANTUS