BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3021278 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06266
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 ULTRAMINI METER WAS DISPLAYING AN "ER 5" MESSAGE. PER THE OWNER'S BOOKLET, THIS MESSAGE APPEARS WHEN THE METER HAD DETECTED A PROBLEM WITH THE TEST STRIP. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE PATIENT'S DAUGHTER REPORTED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON THE AFTERNOON OF (B)(6) 2013. THE REPORTER INFORMED THE CSR THAT THE PATIENT GENERALLY TESTS HER BLOOD GLUCOSE 5-6 TIMES A DAY AND TAKES ORAL MEDICATIONS (METFORMIN AND GLIBENCLAMIDE) TO MANAGE HER DIABETES. THE PATIENT'S DAUGHTER STATED THAT THE PATIENT CONTINUED TO TAKE HER ORAL MEDICATION DESPITE NOT BEING ABLE TO TEST HER BLOOD GLUCOSE AFTER THE ALLEGED METER ISSUE STARTED. ON THE MORNING OF (B)(6) 2013, THE REPORTER CLAIMED THE PATIENT FAINTED AND EMERGENCY SERVICES WAS CONTACTED. THE PATIENT'S DAUGHTER CONFIRMED THE PATIENT'S BLOOD GLUCOSE WAS TESTED WITH THE PARAMEDIC'S METER AND AGAIN WHEN AN ER/HOSPITAL METER AT THE TIME SHE ARRIVED TO THE HOSPITAL. THE REPORTER CONFIRMED THE PATIENT'S BLOOD GLUCOSE REGISTERED AT "52 MG/DL" WITH ANOTHER DEVICE; HOWEVER, COULD NOT CONFIRM IF IT WAS WITH THE PARAMEDIC'S METER OR THE ER/HOSPITAL METER. THE PATIENT'S DAUGHTER REPORTED THE PATIENT WAS TREATED WITH IV GLUCOSE AND WAS HOSPITALIZED UNTIL (B)(6) 2013. THE REPORTER STATED THE PATIENT'S ADMITTING DIAGNOSIS WAS HYPERTENSION AND "OVERDOSE OF GLIBENCLAMIDE." DURING THE FOLLOW-UP CALL, THE REPORTER INFORMED THE CSR THAT THE PATIENT'S HCP INFORMED HER THAT THE PATIENT WAS NOT SUPPOSED TO BE TAKING THE GLIBENCLAMIDE DUE TO HER AGE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS APPLYING THE SAMPLE CORRECTLY TO THE TEST STRIP AND THE TEST STRIPS WERE DRAWING IN THE SAMPLE INTO THE CONFIRMATION WINDOW. THE ALLEGED ISSUE REMAINED UNRESOLVED.REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE SUBJECT METER AND TEST STRIPS WERE REQUESTED TO BE RETURNED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123792 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3391325

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R