BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3770750 · Received April 24, 2014

    Report

    Report Number
    1823260-2014-03026
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHIVERING AND SWEATING WITH A RESULT OF 173 MG/DL OBTAINED ON THE MOBILE SYSTEM. AN AMBULANCE WAS CALLED, AND THE CUSTOMER TESTED 32 MG/DL AND WAS ADMITTED TO THE HOSPITAL (TIMEFRAME BETWEEN THE RESULTS IS NOT KNOWN). THE CUSTOMER RECEIVED IV GLUCOSE AND WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS. THE CUSTOMER'S CONDITION HAS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249120 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278242

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR HUMALOG