BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2060370 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03135
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    April 5, 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN APPROXIMATELY OVER A WEEK AGO PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH 17 UNITS OF HUMULIN R AND N INSULIN TWICE DAILY. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED SHE CONTINUED TO ADMINISTER HER DOSES OF INSULIN AS USUAL. THE PATIENT REPORTED FEELING SHAKY, DESPERATE, AND DEVELOPED A HEADACHE 3 DAYS AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF HER SYMPTOMS, THE PATIENT STATED SHE DID NOT SEEK ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE, THERE WAS NO MISUSED OF THE METER, AND THE METER DID NOT REQUIRE A NEW BATTERY REPLACEMENT. HOWEVER, THE ALLEGED POWER ISSUE WAS NOT RESOLVED SINCE THE POWER BUTTON AND TEST INSERTION PER THE OWNER'S MANUAL DID NOT TURN THE METER ON. 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 SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3067029

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening