BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1821838 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07419
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA 2 METER WOULD NOT POWER ON UPON TEST STRIP INSERTION. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON (B)(6) 2010 AT 10:00 PM, THE PATIENT NOTED THE REPORTED METER WOULD NOT POWER ON WITH THE TEST STRIP INSERTION; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK THE ACTION OF SKIPPING HER DOSE OF THE ORAL DIABETES MEDICATION METFORMIN 500 MG. AT 10:10 PM THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND STRESS. THE PATIENT CONTACTED EMERGENCY SERVICES. PARAMEDICS ARRIVED ON (B)(6) 2010 AT 12:20 AM AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL; THE SPECIFIC RESULT IS UNKNOWN. THE PATIENT RECEIVED NO TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE CORRECT. 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 EMERGENCY MEDICAL ATTENTION. 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. 2805663

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening