BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3911337 · Received July 3, 2014

    Report

    Report Number
    2939301-2014-16261
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 24, 2014
    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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT WAS UNABLE TO CHECK HER BLOOD GLUCOSE WITH HER ONETOUCH ULTRA 2 METER. THE PATIENT WAS TESTING IN THE METER¿S MEMORY MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN AT APPROXIMATELY 9:55AM ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE. THE PATIENT MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF ORAL MEDICATION AND SHE DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 2 MINUTES LATER, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF ¿SHAKING¿ BUT DESPITE HER SYMPTOMS SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. THE ISSUE WAS RESOLVED WITH TRAINING/TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389350 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3569988

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening