BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1231903 · Received November 12, 2008

    Report

    Report Number
    2939301-2008-03067
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 9, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A CALCODE ISSUE WITH THE ONETOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PATIENT. THE PATIENT STATED THAT THE REPORTED ISSUE BEGAN ON NOVEMBER 7, 2008 AT AN UNSPECIFIED TIME. DURING THAT TIME, HE REPORTEDLY HAD DIFFICULTY CHANGING THE CODE ON THE METER. THE PATIENT REPORTEDLY WAS GUESSING ON THE NOVOLOG INSULIN LEVEL FOR SLIDING SCALE AFTER THE REPORTED ISSUE BEGAN AND HE HAD BEEN TAKING THE SHOTS. THE PATIENT STATED THAT ON THE SAME DAY, RIGHT AFTER THE REPORTED ISSUE BEGAN, HE FELT "SHAKY, WOBBLY, WEAK AND FELT LOW" (TIME NOT SPECIFIED). DURING THE REPORTED SYMPTOMS, HE REPORTEDLY COULD NOT TEST ON THE SUBJECT METER SINCE IT WAS NOT WORKING. THE PREVIOUS READINGS PRIOR TO THE REPORTED ISSUE ARE NOT KNOWN. THE PATIENT DID NOT RECEIVE/REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WAS NOT TESTED ON ANY OTHER METER. AT THE TIME OF CALL, IT WAS NOTED THAT THE PATIENT'S GRANDCHILD RESOLVED THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER. THERE IS NO EVIDENCE THAT THE SUBJECT METER MALFUNCTIONED SINCE THE REPORTED ISSUE WAS RESOLVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS, WHICH COULD BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening