BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 2466279 · Received February 23, 2012

    Report

    Report Number
    2939301-2012-01881
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 4, 2012
    Report Date
    February 6, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6), 2012 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS GIVING HER INACCURATE LOW READINGS AS COMPARED TO HER FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ON (B)(6), 2012 AT 5:15PM, SHE OBTAINED THE ALLEGED LOW READING OF "45MG/DL" WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (UNKNOWN TYPE AND DOSAGE) AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. ON THE SAME DAY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "FREQUENT URINATION AND NAUSEA" AND SHORTLY AFTER, RECEIVED TREATMENT OF FOOD/DRINK IN RESPONSE TO THESE SYMPTOMS. THE CCA WAS ALSO INFORMED BY THE PATIENT THAT IMMEDIATELY AFTER THE REPORTED ISSUE BEGAN, THE PATIENT TESTED ON ANOTHER DEVICE (UNKNOWN TYPE) AND OBTAINED A RESULT OF "125MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE UNIT OF MEASURE WAS SET CORRECTLY AT TIME OF TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3180134

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R