BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2573156 · Received May 14, 2012

    Report

    Report Number
    2939301-2012-05118
    Event Type
    Injury
    Date Received
    May 14, 2012
    Date of Event
    May 4, 2012
    Report Date
    May 5, 2012
    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. THE 510(K) # IS K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 IN THE MORNING, THE PATIENT ALLEGED THE ISSUE FIRST OCCURRED. THE PATIENT ALLEGED HE MANAGES HIS DIABETES WITH A COMBINATION OF DIABETIC MEDICATIONS INCLUDING HUMALOG AND LANTUS INSULIN (DOSE UNKNOWN). WHEN THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED HE DID NOT TAKE ANY ACTION BEYOND HIS USUAL DIABETES REGIMEN. HOWEVER ON (B)(6) 2012 30 MINUTES LATER, THE PATIENT ALLEGED FEELING "EXTREME THIRST, EXTREME URINATION, BLURRED VISION, AND TIGHT, DRY SKIN AND FEET" AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED HE DID NOT RECEIVE TREATMENT DUE TO THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT REPLACE THE SUBJECT METER'S BATTERY AS RECOMMENDED IN THE OWNER'S BOOKLET. THE PATIENT DID NOT HAVE THE SUBJECT METER OR TESTING SUPPLIES AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD SUGAR 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 ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening