BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3060163 · Received April 16, 2013

    Report

    Report Number
    1823260-2013-02311
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 19, 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. DEVICE WILL NOT BE RETURNED.

    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. (B)(4).

    Description of Event or Problem · 1

    REPORTER STATED THAT THE CUSTOMER TESTED AND OBTAINED A VALUE OF 205 MG/DL ON THE MOBILE SYSTEM AT AN UNKNOWN TIME IN THE MORNING. THE CUSTOMER TOOK THE "NORMAL" DOSE OF PROTAPHANE (HUMAN NPH INSULIN) AT THIS TIME. IN RESPONSE TO THE HIGH RESULT, THE CUSTOMER DID NOT EAT. APPROXIMATELY 30 MINUTES LATER, THE CUSTOMER BECAME UNCONSCIOUS IN THE CAR PARK OF THE CUSTOMER'S JOB. AT AN UNKNOWN TIME, THE EMERGENCY DOCTOR ARRIVED AND OBTAINED A VALUE OF 24 MG/DL. THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM BY AMBULANCE. THE CUSTOMER RECEIVED A GLUCOSE INFUSION. THE CUSTOMER WAS IN THE EMERGENCY ROOM FOR APPROXIMATELY 30 MINUTES AND THEN RELEASED. THE CUSTOMER IS CURRENTLY FEELING WELL. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION; HOWEVER, THE SUSPECT STRIPS ARE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163363 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR Required Intervention PROTAPHANE INSULIN DAILY INJECTION| PROTAPHANE INSULIN