BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2981371 · Received February 27, 2013

    Report

    Report Number
    1823260-2013-01198
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 6, 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.

    Description of Event or Problem · 1

    REPORTER STATED THAT THE CUSTOMER OBTAINED A VALUE OF 400 MG/DL ON THE MOBILE SYSTEM. IN RESPONSE, THE CUSTOMER TOOK 8-9 UNITS OF HUMALOG INSULIN. APPROXIMATELY 30 MINUTES LATER THE CUSTOMER WAS FOUND UNCONSCIOUS BY HIS WIFE WHO CALLED THE AMBULANCE. THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL WHERE, AT AN UNSPECIFIED TIME, HIS BLOOD GLUCOSE WAS 20-30 MG/DL. THE CUSTOMER WAS TREATED AT THE HOSPITAL WITH GLUCOSE AND A DRUG INFUSION. HE WAS ADMITTED OVERNIGHT AND RELEASED THE NEXT DAY. THE CUSTOMER HAS RECOVERED AND IS CURRENTLY FEELING FINE. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85668 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278172

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR Hospitalization INSULIN PUMP| HUMALOG INSULIN