BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1930892 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10807
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    October 20, 2010
    Report Date
    December 1, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. A 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING A CALCODE ISSUE WITH THE PATIENT'S ONETOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S DAUGHTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT AN UNSPECIFIED TIME. THE DAUGHTER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (METFORMIN 850MG) AND DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE DAUGHTER CLAIMED THAT THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF ORAL MEDICATION AT 7:30 AM THAT MORNING. THE DAUGHTER STATED THE PATIENT BECAME SHAKY 30 MINUTES AFTER THE START OF THE ALLEGED ISSUE. IN SPITE OF THE ALLEGED SYMPTOM, THE DAUGHTER STATED THAT THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS NOT ABLE TO RESOLVE THE ALLEGED ISSUE. THE CCA NOTED AFTER IT WAS CODED CORRECTLY TO 25, THE SUBJECT METER WOULD NOT STAY ON THE CORRECT CODE. THE CODE REVERTS TO CODE 1. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3040722

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening