BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3171778 · Received June 17, 2013

    Report

    Report Number
    3008382007-2013-17447
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS DISPLAYING AN ERROR 1 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT APPROXIMATELY 5:30 PM. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF ORAL MEDICATIONS AND SHE DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. SHE CLAIMED THAT IMMEDIATELY AFTER THE ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF FEELING ¿SICK TO STOMACH, SHAKY AND FAINT¿ BUT DESPITE HER SYMPTOMS SHE DENIED RECEIVING ANY MEDICAL INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272782 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3207873

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening