BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2880799 · Received December 20, 2012

    Report

    Report Number
    3008382007-2012-08721
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 11, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE ONETOUCH ULTRA2 METER SYSTEM KIT WAS MISSING THE SAMPLE LANCETS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 1PM, THE REPORTER ALLEGED THE ISSUE FIRST OCCURRED. THE REPORTER STATED THE PATIENT TAKES NO DIABETES MEDICATIONS TO MANAGE HIS DIABETES. THE REPORTER STATED THE PATIENT MADE NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE REPORTER STATED 48 HOURS AFTER THE ISSUE FIRST OCCURRED, THE PATIENT FELT "SWEATY." THE REPORTER STATED THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THERE WAS NO MISSING PRODUCT IN THE SYSTEM KIT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE REPORTER ALLEGED DUE TO THE ALLEGED ISSUE, THE PATIENT WAS NOT ABLE TO TEST, THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening