BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 2931924 · Received January 28, 2013

    Report

    Report Number
    3008382007-2013-01674
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE PATIENT'S ONETOUCH SELECT SIMPLE READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT'S DAUGHTER REPORTED THAT ON (B)(6) 2013 AT 4PM THE PATIENT TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A READING OF '346 MG/DL.' THE PATIENT TOOK 5 UNITS OF RAPID ACTING INSULIN AND 15 MINUTES LATER, REPORTEDLY FAINTED. EMERGENCY SERVICES WAS CONTACTED AND WHEN THEY ARRIVED AND TESTED THE PATIENT WITH THEIR METER THEY OBTAINED A READING OF '40 MG/DL' AND TREATED THE PATIENT WITH IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE AND THE TEST STRIPS APPEARED TO BE IN GOOD CONDITION AND WERE NOT PAST THEIR EXPIRATION OR DISCARD DATE. THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL TO TEST THE SUBJECT METER AND TEST STRIPS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY WAS TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER SHE LOST CONSCIOUSNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37853 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3352037

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R