BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3150574 · Received June 6, 2013

    Report

    Report Number
    1823260-2013-03418
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 RESULT OF 7.0 MMOL/L OBTAINED ON THE MOBILE SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED 1.5 HOURS LATER. AN AMBULANCE WAS CALLED, AND PARAMEDICS TESTED CUSTOMER ON HER MOBILE RECEIVING A RESULT OF 4.3 MMOL/L. 10 MINUTES LATER THE CUSTOMER TESTED 2.5 MMOL/L ON THE PROFESSIONAL METER. THE PARAMEDICS ADMINISTERED GLUCOGEL AND A GLUCOSE INFUSION. A SHORT TIME AFTER (EXACT TIME FRAME NOT PROVIDED) THE CUSTOMER TESTED 5.4 MMOL/L WITH HER LEFT HAND, AND 10.5 MMOL/L ON HER RIGHT HAND. CUSTOMER TESTED 5.4 MMOL/L ON THE PROFESSIONAL METER AND SHE WAS TAKEN TO THE HOSPITAL. THE CUSTOMER WAS RELEASED FROM THE HOSPITAL 3 HOURS LATER ONCE HER BLOOD SUGAR STABILIZED. NO FURTHER MEDICAL TREATMENT WAS REQUIRED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250117 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278209

    Patients

    Seq Age Sex Outcome Treatment
    1 027 YR NOVORAPID