BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3884661 · Received June 19, 2014

    Report

    Report Number
    1823260-2014-04488
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    January 31, 2014
    Report Date
    July 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
    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. THIS MEDWATCH IS FOR THE MOBILE SYSTEM. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE PERFORMA SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 10 MINUTES: 6.7 MMOL/L (MOBILE SYSTEM) AND 3.6 MMOL/L (PERFORMA SYSTEM). CUSTOMER HAD HYPOGLYCEMIC SYMPTOMS OF "FEELING ILL, HEARING UNUSUAL AND STRANGE FEELING IN HEAD" AT THE TIME OF THESE RESULTS. CUSTOMER SELF-TREATED WITH 8 JELLY BEANS AND FELT BETTER AFTERWARDS. 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
    361113 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278259

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR