BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 4210529 · Received October 29, 2014

    Report

    Report Number
    1823260-2014-08357
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    November 5, 2014
    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
    IT
    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

    CUSTOMER REPORTS TAKING NOVORAPID BASED ON A DEVICE RESULT OF 178 MG/DL OBTAINED ON THE MOBILE SYSTEM. WITHIN 10 MINUTES, HE EXPERIENCED HYPOGLYCEMIC SYMPTOMS. THE CUSTOMER SELF-TREATED WITH 3 GLASSES OF SWEETENED MILK AND AN AMBULANCE WAS CALLED. THE CUSTOMER WAS TAKEN TO HIS CARDIOLOGIST AND WAS TREATED WITH ORAL GLUCOSE TABLETS. AFTER 10 MINUTES THE CUSTOMER'S BLOOD GLUCOSE WAS 72 MG/DL. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691924 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278262

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR Required Intervention NOVORAPID