BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3031745 · Received April 2, 2013

    Report

    Report Number
    3008382007-2013-06830
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT AN UNSPECIFIED MESSAGE ON THE ONE TOUCH ULTRA2 METER. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, AT 1:00 PM, THE PATIENT NOTED SHE WAS UNABLE TO GET TO THE METER'S MAIN DISPLAY SCREEN IN ORDER TO TEST HER BLOOD GLUCOSE LEVEL. AFTERWARDS, THE PATIENT EXPERIENCED "LOW BLOOD SUGAR" SYMPTOMS. THE PATIENT DID NOT REPORT SEEKING ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE INJURY AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE, THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135223 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3403598

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening