BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3173366 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03631
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 18, 2013
    Report Date
    July 16, 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
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CASE NOTES CUSTOMER IS IN HIS "MID (B)(6)." 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

    THE REPORTER STATES PATIENT HAD BEEN OBTAINING, FOR THE PRECEDING TEN OR SO DAYS, CONSISTENTLY HIGH SMBG VALUES, IN THE 20 MMOL/L RANGE ON HIS MOBILE SYSTEM 1; THE CUSTOMER HAD BEEN INJECTING RAPID ACTING INSULIN BASED UPON THESE VALUES AND DEVELOPING HYPOGLYCEMIC SYMPTOMS IN ABOUT 30 MINUTES. AS A RESULT, HE HAD BEEN TAKEN TO THE HOSPITAL FOR 3-4 HOURS OBSERVATION SEVERAL TIMES. ON THE SATURDAY PRIOR TO THE REPORT, HE HAD CLEAR SYMPTOMS OF HYPOGLYCEMIA INCLUDING: TREMBLING, ANXIETY AND HEADACHE. A SMBG VALUE ON HIS MOBILE SYSTEM 1 WAS 5.5 MMOL/L. AFTER FIVE MINUTES HE FAINTED. AFTER 10-15 MINUTES THE AMBULANCE CAME AND MEASURED HIS GLUCOSE AT 1.5 MMOL/L. HE WAS TREATED AND HOSPITALIZED FOR 3 DAYS. THE CUSTOMER HAS RECOVERED AND IS NOW STABLE. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273840 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278225

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R