BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2023850 · Received March 18, 2011

    Report

    Report Number
    2939301-2011-02355
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A TEST STRIP HOLDER/ PORT ISSUE WITH HIS ONETOUCH ULTRA METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AN UNKNOWN TIME. THE PATIENT INFORMED THE CCA THAT THERE WAS SOMETHING IN THE SUBJECT METER THAT WAS PREVENTING HIM FROM INSERTING THE TEST STRIP. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH INSULIN. DUE TO THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES REGIMEN. THE PATIENT REPORTEDLY BECAME SWEATY A WEEK AFTER THE ALLEGED ISSUE BEGAN. IS SPITE OF HIS SYMPTOM, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THERE WAS NO MISUSED OF THE SUBJECT METER AND THE PATIENT WAS NOT A FIRST TIME USER OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3069640

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening