BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1955348 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00305
    Event Type
    Injury
    Date Received
    January 10, 2011
    Report Date
    December 17, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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), 2010, THE LAY USER/PATIENT'S NURSE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA METER WAS POWERING OFF DURING USE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6), 2011 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HER TESTING FREQUENCY IS TWICE DAILY IN THE MORNING AND EVENING AND MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN 500MG) TWICE DAILY. THE PATIENT CONFIRMED/VERIFIED THE ALLEGED ISSUE BEGAN ON AN UNSPECIFIED DATE AND TIME PRIOR TO CONTACTING LFS. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT ROUTINE. AT AN UNSPECIFIED DATE AND TIME, THE PATIENT CLAIMED SHE HAD AN INCREASED IN APPETITE, WAS FEELING THIRSTY, AND DEVELOPED SYMPTOMS OF FREQUENT URINATION AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF THE SYMPTOMS, THE PATIENT CONFIRMED/VERIFIED SHE DID NOT SEEK ANY MEDICAL TREATMENT. ACCORDING TO THE PATIENT, NO OTHER BLOOD GLUCOSE METER WAS USED AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE PRODUCTS HAVE BEEN USED BEFORE, THERE WAS NO MISUSED OF THE PRODUCTS, AND THE SUBJECT METER NEEDED NEW BATTERIES; HOWEVER THE NURSE INFORMED THE CCA THAT THE PATIENT DID NOT HAVE BATTERIES AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S NURSE CLAIMS THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY BECAME HYPERGLYCEMIC 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. 2820634

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening