BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3233694 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20272
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 10, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS FROM ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED ON (B)(6) 2013 AT APPROXIMATELY 4 PM PRIOR TO THE START OF THE ALLEGED ISSUE, SHE WAS TAKING A NAP UPSTAIRS AND WAS ABLE TO WALK DOWNSTAIRS AND WAS ¿COMPLETELY OUT OF IT, AND COULD NOT REMEMBER ANYTHING.¿ THE PATIENT REPORTED SHE WAS FOUND TO BE ¿AWAKE BUT DISORIENTED WHILE SITTING IN FRONT OF A BLANK TV SCREEN.¿ THE PATIENT REPORTED HER SON FOUND HER ON THE COUCH AND TOLD HER SHE WAS ACTING STRANGE AND WOULD ¿REFUSE TO DO ANYTHING.¿ THE PATIENT REPORTED HER SON TESTED HER ON THE SUBJECT METER AND OBTAINED A READING OF ¿88 MG/DL¿ WHICH HER HUSBAND BELIEVED TO BE TOO HIGH AND RESTED MINUTES LATER AND OBTAINED A READING OF ¿81 MG/DL¿ ON THE SAME METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF (B)(4) WHEN OBTAINED WITHIN 20 MINUTES. THE PATIENT REPORTED HER SON BROUGHT HER SOME ORANGE JUICE AS TREATMENT. THE PATIENT REPORTED 15-20 MINUTES AFTER THE ALLEGED ISSUE STARTED HER HUSBAND TESTED HER BLOOD GLUCOSE ON A ONETOUCH ULTRA METER AND OBTAINED A READING OF ¿51 MG/DL¿ AND GAVE HER MORE JUICE AND HER SYMPTOMS ABATED. THE PATIENT DENIED BEING TREATED BY EMERGENCY MEDICAL SERVICES (EMS) OR GOING TO THE HOSPITAL. THE PATIENT REPORTED SHE NORMALLY TESTS 6-7 TIMES A DAY AND SHE TYPICALLY TARGETS ¿150 MG/DL.¿ THE PATIENT REPORTED SHE USES HUMALOG INSULIN PUMP THERAPY TO MANAGE HER DIABETES AND ADJUSTS ACCORDING TO READINGS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS WERE IN GOOD CONDITION. WHEN A CONTROL SOLUTION TEST WAS RUN, THE RESULT WAS NOT WITHIN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, WHILE HAVING SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA, SHE HAD A DELAY IN TREATMENT AND REQUIRED ASSISTANCE FROM A THIRD NON HEALTHCARE PROFESSIONAL PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336112 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3437789

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R