BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2083343 · Received May 10, 2011

    Report

    Report Number
    2939301-2011-03844
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 30, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 HIS ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN IN LATE (B)(6) (YEAR NOT SPECIFIED). THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT 2 MONTHS AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMED HIS LEGS "GAVE OUT," HAD WHITE FOAM IN HIS MOUTH, FELT EXTREME FATIGUE AND FREQUENT URINATION. ON (B)(6) 2011, THE PATIENT STATED HE WAS ADMITTED INTO THE HOSPITAL AND ADMINISTERED INTRAVENOUS (IV) FLUIDS AS TREATMENT. ON (B)(6) 2011 AT 2PM, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "135 MG/DL" WITH THE ER/ HOSPITAL METER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA WAS UNABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R