BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3253530 · Received July 30, 2013

    Report

    Report Number
    3008382007-2013-21394
    Event Type
    Injury
    Date Received
    July 30, 2013
    Report Date
    July 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRASMART METER WAS READING CONTROL SOLUTION INACCURATELY HIGH WHEN HE RAN A CONTROL SOLUTION TEST AND WAS READING INACCURATELY COMPARED TO THE SAME METER. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ¿LATE LAST YEAR¿ PRIOR TO CONTACTING LFS THE ALLEGED ISSUES FIRST BEGAN. THE PATIENT REPORTED OBTAINING A READING OF ¿198MG/DL¿ ON THE LFS METER WITH CONTROL SOLUTION AND COULD NOT RECALL WHAT READINGS WERE OBTAINED WITH BLOOD ON THE LFS METER. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED SOME TIME LATER HE DEVELOPED SYMPTOMS OF ¿SICK TO STOMACH, LIGHT HEADED AND NUMBNESS.¿ THE PATIENT REPORTED ¿LATE LAST YEAR¿ HE OBTAINED A ¿HI¿ READING ON A ONETOUCH ULTRAMINI METER AND SELF ADMINISTERED ¿EXTRA INSULIN (UNKNOWN TYPE AND DOSE). AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS USING THE CORRECT CONTROL SOLUTION AND THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT¿S TESTING PROCESS WAS CORRECT. THE PATIENT¿S TEST STRIPS, TEST STRIPS VIAL AND CONTROL SOLUTION WERE FOUND TO BE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE HE OBTAINED A ¿HI¿ MESSAGE ON ANOTHER METER INDICATING BLOOD GLUCOSE LEVELS OF OVER ¿600MG/DL¿ AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354486 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL BA2A34

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R