BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3173316 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03632
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 18, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IS IN HIS "MID-(B)(6)." 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 PATIENT#S MOBILE SYSTEM 2 COMPARED TO A PROFESSIONAL METER WITHIN 10 MINUTES: 27 MMOL/L (MOBILE SYSTEM 2) AND 11.0 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
    273046 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278225

    Patients

    Seq Age Sex Outcome Treatment
    1