BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3180171 · Received June 20, 2013

    Report

    Report Number
    1823260-2013-03750
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    July 24, 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. (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED CUSTOMER WOKE UP IN THE MORNING OF AND HE WAS VERY GROGGY AND KEPT FALLING OVER. HIS FATHER SAT HIM DOWN ON A CHAIR AND CUSTOMER HAD A SEIZURE. MOTHER OF CUSTOMER REALIZED THAT HE HAD LOW BLOOD SUGAR AND TESTED WITH MOBILE SYSTEM 1 WITH STRIP LOT 278197 AND OBTAINED A RESULT OF 5.7 MMOL/L. MOTHER PERFORMED ANOTHER BLOOD TEST WITH MOBILE SYSTEM 2 WITH STRIP LOT 278212 AND OBTAINED A READING OF 4.7 MMOL/L. MOTHER THEN TESTED WITH A COMPETITOR METER AND THE RESULT WAS 2.7 MMOL/L. ALL THREE BLOOD GLUCOSE TESTS WERE DONE WITHIN TWO MINUTES. THE CUSTOMER'S PARENTS CALLED AN AMBULANCE. AT AN UNKNOWN TIME, THE AMBULANCE PERSONNEL ARRIVED AND PERFORMED A BLOOD SUGAR TEST WITH A RESULT OF 1.8 MMOL/L. CUSTOMER WAS GIVEN "SUGAR AND GLUCOSE" BY THE PARAMEDICS. HIS BLOOD SUGAR LEVEL BEGAN TO RISE AND THE PARAMEDICS LEFT. CUSTOMER WAS NOT TRANSPORTED TO THE HOSPITAL AND HE FEELS FINE PRESENTLY. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280073 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278212

    Patients

    Seq Age Sex Outcome Treatment
    1 011 YR