BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3272457 · Received August 8, 2013

    Report

    Report Number
    3008382007-2013-22246
    Event Type
    Injury
    Date Received
    August 8, 2013
    Report Date
    July 24, 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
    OH, 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 HER ONETOUCH ULTRAMINI METER WAS DISPLAYING INACCURATE RESULTS WHEN COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED DURING THE BEGINNING OF (B)(6) 2013. THE PATIENT REPORTED ON (B)(6) 2013 THROUGHOUT THE DAY SHE OBTAINED READINGS OF ¿120, 110, 146, 342 AND 140MG/DL.¿ THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED AT AN UNKNOWN TIME LATER, SHE DEVELOPED SYMPTOMS OF ¿HEADACHE, INSOMNIA, BLURRED VISION, LOSS OF BALANCE. THE PATIENT DENIED RECEIVING ANY TREATMENT DUE TO THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING. THE PATIENT REPORTED HER TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMED DUE TO THE ALLEGED ISSUE SHE MADE NO CHANGES TO HER USUAL ROUTINE AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374606 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3468993

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening