BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3771070 · Received April 24, 2014

    Report

    Report Number
    1823260-2014-03047
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    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.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS ON MOBILE SYSTEM COMPARED TO A PROFESSIONAL METER WITHIN 10 MINUTES: 4.9 MMOL/L, 5.8 MMOL/L, 3.9 MMOL/L AND HI (RESULT > 33.3 MMOL/L) MOBILE SYSTEM AND 25.4 MMOL/L (PROFESSIONAL METER). PATIENT HAD NO SYMPTOMS, HOWEVER, NURSE TREATED PATIENT WITH 8 UNITS OF NOVORAPID BASED ON THE RESULT OF 25.4 MMOL/L. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249576 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 27825244

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR