BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3211775 · Received July 8, 2013

    Report

    Report Number
    1823260-2013-04128
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 18, 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.

    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 RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    REPORTER STATED CUSTOMER WAS FEELING VERY LOW AND TESTED HER BLOOD WITH THE MOBILE SYSTEM AT 9:00 AND OBTAINED A RESULT OF 6.6 MMOL/L. THE CUSTOMER THOUGHT THAT THIS WAS INCORRECT. SHE DID NOT TAKE ANY ACTION DUE TO THAT RESULT. SOMETIME BETWEEN 9:00 AND 9:15, THE CUSTOMER FELL INTO A "DIABETIC COMA" AND WAS UNCONSCIOUS; THE FAMILY WAS NOT ABLE TO HELP HER AND CALLED THE PARAMEDICS. THE AMBULANCE ARRIVED AT 9:15 AND CHECKED HER BLOOD WITH THEIR OWN DEVICE AND IT SHOWED 2.7 MMOL/L. CUSTOMER WAS TREATED WITH GLUCAGON INJECTIONS AND WAS ADMITTED TO THE HOSPITAL FOR THE NEXT 12 HOURS. THE CUSTOMER IS CURRENTLY FEELING FINE AND HAS FULLY RECOVERED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309843 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278220

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR NOVOMIX 30 - 2X'S A DAY