BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3143450 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14706
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 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
    NM, 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/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WAS GIVING THE ERROR 5 AND ERROR 2 ERROR MESSAGES. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, AT 7:10 PM, THE PATIENT OBTAINED THE ERROR 5 AND ERROR 2 ERROR MESSAGES ON THE REPORTED METER; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. TEN MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND DIZZINESS; SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT¿S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT, AND THE TEST STRIPS CORRECTLY DREW IN THE BLOOD SAMPLE. THE ISSUES WERE NOT RESOLVED. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER NOT BEING ABLE 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
    243993 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3444215

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening