BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2103088 · Received May 25, 2011

    Report

    Report Number
    2939301-2011-04382
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 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 REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 10:00AM. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED SHE IS ON NOVOLOG PEN INSULIN (10UNITS/SLIDING SCALE) AND LANTUS INSULIN (50 UNITS EVERY EVENING) . DESPITE THE ALLEGED ISSUE, THE PATIENT STATED SHE CONTINUED TO ADMINISTER HER USUAL DOSES OF INSULIN. IMMEDIATELY AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT REPORTED FEELING SHAKY. IN SPITE OF HER SYMPTOM, 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, THERE WAS NO MISUSED OF THE METER, AND THE BATTERIES REQUIRED NO REPLACING. THE POWER BUTTON AND TEST STRIP INSERTION DID NOT TURN THE METER ON PER THE OWNER'S MANUAL. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF 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. 2883049

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening