BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3800084 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03293
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 30, 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.

    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.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT RECEIVED A RESULT OF 3.6 MMOL/L (MOBILE SYSTEM) AND EXPERIENCED HYPOGLYCEMIC SYMPTOMS. HE WAS TREATED WITH DEXTROSE TABLETS. FIFTEEN MINUTES LATER, THE FOLLOWING RESULTS WERE TAKEN ON THE MOBILE SYSTEM AND COMPARED TO A PROFESSIONAL METER WITHIN 2 MINUTES: 15.6 MMOL/L (MOBILE SYSTEM) AND 7.8 MMOL/L (PROFESSIONAL METER). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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
    278751 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278293

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR