BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 802049 · Received January 2, 2007

    Report

    Report Number
    2939301-2006-01705
    Event Type
    Injury
    Date Received
    January 2, 2007
    Date of Event
    December 17, 2006
    Report Date
    December 18, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON DECEMBER 18, 2006, THE LAY PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE PATIENT OBTAINED RESULTS OF 190, 212, AND 225 MG/DL ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER BEFORE EXPERIENCING SYMPTOMS. THE READINGS WERE WITHIN PRECISION SPECIFICATIONS. HE TOOK 10 UNITS OF LANTUS INSULIN FOLLOWING USE OF THE METER. THE PATIENT EXPERIENCED DIZZINESS AND DOUBLE VISION AT THE TIME OF CONCERN; THE TIME DIFFERENCE BETWEEN THE PATIENT TAKING INSULIN AND EXPERIENCING SYMPTOMS WAS NOT PROVIDED. THE PATIENT RECEIVED ASSISTANCE FROM EMERGENCY SERVICES, A READING OF 46 WAS OBTAINED ON ANOTHER DEVICE, AND THE PATIENT WAS TREATED WITH IV GLUCOSE. THE CUSTOMER CARE ADVOCATE (CCA) DISCOVERED THAT THE PATIENT WAS NOT STORING THE TEST STRIPS CORRECTLY IN THE TEST STRIP VIAL, WHICH CAN CAUSE INACCURATE READINGS. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT TOOK INSULIN AFTER TESTING WITH INCORRECTLY STORED TEST STRIPS. THE PATIENT EXPERIENCED SYMPTOMS AND A HYPOGLYCEMIC READING WAS OBTAINED BY EMERGENCY SERVICES. THE PATIENT WAS TREATED WITH IV GLUCOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening| R