BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2062861 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03216
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    April 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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'S SISTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER WAS IN THE SETTINGS MODE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT'S SISTER ALLEGED THAT THE ISSUE BEGAN AT 8:15PM, HOWEVER, THE DATE WAS NOT PROVIDED. IN ADDITION TO ORAL MEDICATION (TYPE AND DOSAGE NOT SPECIFIED), THE PATIENT ALSO MANAGES HIS DIABETES WITH DIET AND/OR EXERCISE. THE PATIENT'S SISTER DENIED THE PATIENT TOOK ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. AS A RESULT OF THE PRODUCT ISSUE, THE PATIENT'S SISTER CLAIMED THE PATIENT DEVELOPED SYMPTOMS OF BLURRY VISION, TIREDNESS, AND SHAKING 45 MINUTES LATER. THE PATIENT'S SISTER DENIED THE PATIENT RECEIVED ANY TREATMENT AFTER THE REPORTED METER ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR GUIDED THE PATIENT'S SISTER THROUGH THE PROPER TESTING PROCEDURE AND THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT. 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3105181

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening