BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2538963 · Received April 18, 2012

    Report

    Report Number
    2939301-2012-03808
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRASMART METER WOULD POWER OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF CHANGES WERE MADE TO THE PATIENT'S USUAL DIABETES MANAGEMENT ROUTINE. AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKY AND HUNGRY. THE PATIENT TREATED SELF WITH FOOD AND/ OR DRINK. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. THE BATTERIES DID NOT NEED TO BE REPLACED IN THE SUBJECT METER. THE CCA TRIED TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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 ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3278042

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R