BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3212258 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19173
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    July 1, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER WAS DISPLAYING AN ERROR 2 MESSAGE. ACCORDING TO THE OT ULTRAMINI OWNER¿S MANUAL, AN ERROR 2 COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. IT IS UNKNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED A FEW HOURS AFTER THE ALLEGED ISSUE OCCURRED, HE DEVELOPED SYMPTOMS OF ¿BLURRY VISION.¿ THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. DURING THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE PRODUCT. THE CCA CONFIRMED WHEN THE POWER BUTTON WAS PRESSED, THE METER DID NOT POWER ON. THE CCA DISCOVERED THE PATIENT WAS USING AN INCORRECT TESTING PROCESS; HE WAS PUTTING THE BLOOD SAMPLE ON THE TEST STRIP PRIOR TO INSERTION IN THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE PRODUCTS WERE REQUESTED FOR RETURN. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TEST AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313452 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3305045

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening