BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1231911 · Received November 12, 2008

    Report

    Report Number
    2939301-2008-03087
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. 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/PT CONTACTED LIFESCAN (LFS) ALLEGING AN APPLY SAMPLE ISSUE WITH THE ONETOUCH ULTRAMINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PT STATED THAT THE REPORTED ISSUE BEGAN ON THE SAME DAY BETWEEN 7 AM AND 8 AM. DURING THAT TIME, THERE WAS AN APPLY SAMPLE ISSUE WITH THE SUBJECT METER AND REPORTEDLY DID NOT OBTAIN ANY BLOOD GLUCOSE READINGS DUE TO THE REPORTED ISSUE. THE PT REPORTEDLY DID NOT TAKE ANY DIABETIC TREATMENT ACTIONS FOLLOWING THE REPORTED ISSUE. THE PT DID NOT DEVELOP ANY SYMPTOMS BEFORE, DURING OR AFTER THE REPORTED ISSUE. ON THE SAME DAY AT 10 PM, THE PT REPORTEDLY RECEIVED ASSISTANCE FROM THE EMERGENCY ROOM AND REPORTEDLY OBTAINED A READING OF "200 MG/DL" ON THE ER/HOSPITAL METER. THE PT REPORTEDLY RECEIVED 35 UNITS OF NOVOLOG INSULIN AT THE HOSPITAL. DURING THE TROUBLESHOOTING, THE CCA NOTED THAT THE PT WAS USING THE CORRECT TECHNIQUE FOR SAMPLE APPLICATION AND THE TEST STRIP DREW THE SAMPLE INTO THE TEST AREA. THE PT DID NOT HAVE A NEW VIAL OF TEST STRIPS AT THE TIME OF CALL TO SEE IF THE ISSUE WAS RESOLVED. THE PT'S PRODUCTS WERE REPLACED. BASED ON THE PROVIDE INFO, THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE AFTER THE REPORTED ISSUE, THE PT REPORTEDLY RECEIVED TREATMENT AT THE EMERGENCY ROOM, WHICH COULD BE SUGGESTIVE OF TREATMENT FOR A HYPERGLYCEMIC EVENT. IN ADDITION, THE REPORTED ISSUE WAS NOT RESOLVED DURING THE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2829312

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening