BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1843077 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08327
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 4, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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#: K062195.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE LAY USER/REPORTER, THE PATIENT'S WIFE, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS GIVING INACCURATELY LOW READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6), 2010, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 17 MG/DL ON THE REPORTED METER, WHICH HE CLAIMED WAS INACCURATELY LOW. THE PATIENT TOOK THE ACTION OF CONSUMING MORE FOOD AND/OR DRINK. ON (B)(6), 2010, THE PATIENT EXPERIENCED THE SYMPTOMS OF BEING "LIFELESS", TIRED AND INABILITY TO WALK. EMERGENCY SERVICES WERE CONTACTED. WHEN PARAMEDICS ARRIVED, THEY TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 300 MG/DL. THE PATIENT WAS TRANSPORTED TO AND ADMITTED TO THE HOSPITAL. THE REPORTER WAS UNABLE TO PROVIDE DETAILS ABOUT HIS TREATMENT. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE CUSTOMER CARE ADVOCATE (CCA) DETERMINED THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE CCA ALSO DETERMINED THE TEST STRIPS WERE EXPIRED OR STORED IMPROPERLY, WHICH CAN CAUSE INACCURATE READINGS. THE METER WAS REPLACED. THE PATIENT USED EXPIRED OR IMPROPERLY STORED TEST STRIPS. THE PATIENT ALLEGEDLY BECAME HYPERGLYCEMIC AFTER HE OBTAINED LOW BLOOD GLUCOSE READINGS ON THE REPORTED METER AND CONSUMED MORE FOOD, AND RECEIVED EMERGENCY MEDICAL ATTENTION. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening