BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2415160 · Received January 13, 2012

    Report

    Report Number
    2939301-2012-00516
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (SERIAL #) INFORMATION WAS NOT PROVIDED. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS REVERTING TO THE SETUP MODE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 11AM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, ACCORDING TO THE CSR'S DOCUMENTATION IN RESPONSE TO THE REPORTED METER ISSUE THE PATIENT CONSUMED LESS FOOD/DRINK. AN HOUR AFTER THE REPORTED METER ISSUE OCCURRED, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF BLURRY VISION AND FREQUENT URINATION. THE PATIENT, HOWEVER, DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION/ TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE ALLEGED ISSUE OCCURRED AFTER THE SUBJECT METER'S BATTERIES WERE REPLACED. THE ALLEGED ISSUE WAS RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3026320

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening