BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3111984 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02932
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH A RESULT OF 169 MG/DL OBTAINED ON THE MOBILE SYSTEM. AN AMBULANCE WAS CALLED, AND APPROXIMATELY 15-20 MINUTES LATER, THE CUSTOMER TESTED 45 MG/DL ON THE PROFESSIONAL METER. HE WAS TREATED WITH LIQUID GLUCOSE AND ADMITTED TO THE HOSPITAL. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER ONLY THE METER WAS RETURNED; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213298 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278191

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR Hospitalization| R UNKNOWN INSULIN