BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2101145 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04340
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S DAUGHTER CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S DAUGHTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 7:30AM. THE DAUGHTER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH INSULINS. DESPITE THE ALLEGED ISSUE, THE DAUGHTER INDICATED THAT THE PATIENT CONTINUED TO ADMINISTER HER USUAL DOSE OF LANTUS (20 UNITS, 2X DAILY) AND HUMALOG (15 UNITS, 3X DAILY). A DAY AFTER THE ALLEGED ISSUE BEGAN, THE DAUGHTER STATED THE PATIENT DEVELOPED SYMPTOMS OF DRY MOUTH AND FREQUENT URINATION. ACCORDING TO THE DAUGHTER, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THE METER WAS NO MISUSED, THE BATTERIES NEEDED NO REPLACING, AND THE CORRECT TEST STRIPS WERE USED; HOWEVER THE ALLEGED POWER ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DAUGHTER CLAIMS THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA 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. 3130027

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening