BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1853166 · Received October 5, 2010

    Report

    Report Number
    2939301-2010-08766
    Event Type
    Injury
    Date Received
    October 5, 2010
    Report Date
    September 22, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. A 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS REVERTING TO THE SET UP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN SEVERAL WEEKS PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH PILLS AND DIET/ EXERCISE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE HAD LESS FOOD AND/OR DRINK. ON AN UNSPECIFIED DATE, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STATED SHE WAS FEELING HOT AND SWEATY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT AS A RESULT OF THE ALLEGE ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER REVERTED TO THE SET UP MODE AFTER BATTERY HAD BEEN REPLACED. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE STILL 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. 3004364

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening