BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3140222 · Received May 31, 2013

    Report

    Report Number
    3008382007-2013-14037
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K002134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS REVERTED TO THE SETUP MODE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT NOTED THE REPORTED METER HAD REVERTED TO THE SETUP MODE; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF HEADACHE, SWEATING, NAUSEA AND ANXIETY. THE PATIENT DID NOT REPORT SEEKING ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE METER AND TEST STRIPS WERE REPLACED. THE METER ISSUE WAS RESOLVED WITH PATIENT EDUCATION, INDICATING THERE WAS NO MALFUNCTION. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE INJURY AFTER THE ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242013 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3417486

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening