BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3888736 · Received June 23, 2014

    Report

    Report Number
    1823260-2014-04567
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 23, 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). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278289, EXPIRATION DATE 06/30/2015). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED THE FOLLOWING COMPACT PLUS/MOBILE RESULTS: 1) 3.7 MMOL/L AND 11.0 MMOL/L (22:11) 2) 3.3 MMOL/L AND 10.7 MMOL/L (22:20) 3) 2.5 MMOL/L AND 3.2 MMOL/L (22:24) 4) 5.2 MMOL/L AND 13.4 MMOL/L (10:35) 5) 3.6 MMOL/L AND 7.2 MMOL/L (16:34) 6) 3.2 MMOL/L AND 3.9 MMOL/L (16:41) 7) 6.3 MMOL/L AND HI (GREATER THAN 33.3 MMOL/L) (18:59) THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. 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
    366192 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278289

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR NOVOMIX| GLUCOPHAGE