BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2932626 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01718
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 8, 2013
    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

    Additional Manufacturer Narrative · 1

    (SERIAL #) INFORMATION WAS NOT PROVIDED. TEST STRIP LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN APPROXIMATELY TWO WEEKS PRIOR TO CONTACTING LFS. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE. THE PATIENT, HOWEVER, DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED POWER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED METER ISSUE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM OF FREQUENT URINATION THREE DAYS LATER. ON (B)(6) 2013 THE PATIENT WAS ADVISED BY HER HEALTH CARE PROFESSIONAL (BY PHONE) TO MAKE AN APPOINTMENT FOR URINALYSIS. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING THE CSR NOTED THAT THE PATIENT DID NOT HAVE HER TESTING SUPPLIES AVAILABLE. THE ALLEGED POWER ISSUE REMAINS UNRESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38441 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening