BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3910641 · Received July 2, 2014

    Report

    Report Number
    1823260-2014-04861
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    August 19, 2014
    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
    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

    REPORTER STATED CUSTOMER HAD HYPOGLYCEMIC SYMPTOMS (E.G. EYES BECAME BIG, COULD NOT TALK) AND CUSTOMER'S WIFE GAVE HIM "GLUCOSE." NO TEST ON THE MOBILE SYSTEM WAS REPORTED AT THIS TIME. APPROXIMATELY 2 HOURS LATER, CUSTOMER TESTED ON THE MOBILE SYSTEM AND THE RESULT WAS HI (RESULT > 33.3 MMOL/L). AT THIS TIME, THE CUSTOMER STILL HAS SIGNS OF HYPOGLYCEMIA. DUE TO THIS READING, AN UNSPECIFIED TYPE AND AMOUNT OF INSULIN WAS ADMINISTERED. APPROXIMATELY 30 MINUTES LATER, THE CUSTOMER TESTED ON THE MOBILE SYSTEM AGAIN WITH A RESULT OF HI (RESULT > 33.3 MMOL/L). AN UNSPECIFIED TYPE AND AMOUNT OF INSULIN WAS AGAIN TAKEN. APPROXIMATELY 10 - 15 MINUTES LATER, ANOTHER TEST WITH THE MOBILE SYSTEM YIELDED A VALUE OF 23.6 MMOL/L. CUSTOMER'S CONDITION WAS DETERIORATING AND HE WAS STILL EXPERIENCING HYPOGLYCEMIC SYMPTOMS WHEN HE INJECTED AN UNSPECIFIED TYPE AND AMOUNT OF INSULIN AGAIN. AT AN UNKNOWN TIME LATER, CUSTOMER BEGAN TO HALLUCINATE, WAS DELIRIOUS AND "ALL OVER THE PLACE". CUSTOMER'S WIFE CALLED THE PARAMEDICS WHO ARRIVED 10 - 15 MINUTES LATER. THE PARAMEDICS TREATED THE CUSTOMER WITH "GLUCOSE" AND OXYGEN AND TESTED HIM WITH THEIR METER AND THE RESULT WAS 2.0 MMOL/L. CUSTOMER WAS TRANSPORTED TO THE HOSPITAL. IN THE HOSPITAL, HE WAS TREATED WITH "GLUCOSE AND FOOD." WHILE IN THE HOSPITAL, THE CUSTOMER TESTED AGAIN ON HIS MOBILE SYSTEM AND OBTAINED A READING OF 16.0 MMOL/L. CUSTOMER WAS HOSPITALIZED FOR 3 - 4 HOURS. CUSTOMER HAS SINCE 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
    387742 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR Hospitalization| R UNSPECIFIED INSULIN