BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 4260682 · Received November 19, 2014

    Report

    Report Number
    2939301-2014-31219
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 11, 2014
    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
    GA, 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS POWERING OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO SAY WHEN THE METER BEGAN TO POWER OFF DURING USE. THE PATIENT REPORTED THAT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. AT 9:00AM ON (B)(6) 2014, SHE REPORTED CONSUMING MORE FOOD/DRINK AS A RESULT OF THE PROBLEM SHE EXPERIENCED WITH THE METER. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE PRODUCT ISSUE BUT REPORTED, ALSO AT 9:00AM ON (B)(6)2014, SHE WAS TREATED AT AN URGENT CARE/CLINIC WITH MORE FOOD/DRINK BY A HEALTHCARE PROFESSIONAL (HCP). SHE DENIED USING ANY OTHER DEVICE TO TEST HER BLOOD GLUCOSE LEVELS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THE CCA ALSO NOTED THAT BASED ON THE INFORMATION THE PATIENT PROVIDED, THE BATTERY DID NOT NEED REPLACING AND THERE WAS NO REPORT OF TRAUMA/MISUSE TO THE DEVICE. THE ALLEGED ISSUE REMAINED UNRESOLVED AFTER TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DID NOT REPORT SIGNS OR SYMPTOMS OF AN ACUTE DIABETES EXCURSION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED TREATMENT OF THE TYPE ADMINISTERED FOR SEVERE HYPOGLYCEMIA FROM A HCP, AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750807 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3619836

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R