BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2223771 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08131
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 510K#: K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA2 METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. FOR TWO DAYS, THE PATIENT CLAIMED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS. AFTERWARDS, ON (B)(6) 2011 AT 10:00 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF BEING "CLAMMY" AND SHAKING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR A DRINK; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE CORRECT, AND THE METER POWERED ON SUCCESSFULLY WITH BOTH THE POWER BUTTON AND THE TEST STRIP. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE REPORTED METER POWER ISSUE, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043216

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R