BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2220928 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07937
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED THE REPORTED METER FOR INVESTIGATION. PRODUCT ANALYSIS WAS PERFORMED, AND THE METER PASSED TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE SR. MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HER BY TELEPHONE. ON (B)(4) 2011, THE SMSS MAILED A LETTER REQUESTING SHE CONTACT MEDICAL SURVEILLANCE. ON APPROXIMATELY (B)(6) 2011, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT NOTED SHE TOOK HER USUAL DOSE OF 70/30 INSULIN 65 UNITS IN THE MORNING AND EVENING, DESPITE THE METER ISSUE. ONE TO TWO HOURS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF BODY PAIN, STOMACH PAIN, SWEATING AND ANXIETY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE METER POWERED ON SUCCESSFULLY WITH BOTH THE TEST STRIP AND THE POWER BUTTON. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THE REPORTED SYMPTOMS WERE THE PATIENT'S SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, THE PATIENT'S BLOOD GLUCOSE READINGS FROM EARLIER THAT DAY AND IF THE PATIENT HAD A BACKUP METER. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING DUE TO THE METER POWER ISSUE. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3126956

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening