BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 2466184 · Received February 23, 2012

    Report

    Report Number
    2939301-2012-01876
    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
    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 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 REVERTING BACK TO THE SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THE ALLEGED ISSUE BEGAN ON (B)(6), 2012 AT 11:30AM. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. AT AN UNSPECIFIED TIME ON (B)(6), 2012, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF "SHAKINESS AND BLURRY VISION" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. DURING THE TROUBLESHOOTING, THE CCA WAS ABLE TO WALK THE PATIENT THROUGH THE CORRECT TESTING PROCEDURES AS RECOMMENDED PER THE OWNER'S BOOKLET AND THE REPORTED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN, THIS COMPLAINT IS BEING REPORTED BECAUSE SHE CLAIMED TO HAVE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3166300

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening