BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2042646 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02851
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS DISPLAYING THE "ERROR 3" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 7:00AM. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH AN INSULIN PUMP. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED HE INCREASED HIS DOSE OF MEDICATION; HOWEVER TYPE AND DOSE OF MEDICATION DOCUMENTED WAS UNCLEAR. THE PATIENT CLAIMED 2 HOURS AFTER THE ALLEGED ISSUE BEGAN, HE REPORTEDLY FELT SHAKY, NAUSEAS, DEAF, PAIN IN THE EAR, AND DEVELOPED A HEADACHE. ON (B)(6) 2011 AT 4:00PM, THE PATIENT CLAIMED HE WENT TO SEE HIS HEALTH CARE PROVIDER (HCP) FOR ASSISTANCE; HOWEVER IT IS NOT KNOWN WHAT TYPE OF TREATMENT, IF ANY, THE PATIENT RECEIVED WHILE AT THE DOCTOR'S OFFICE VISIT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT; HOWEVER THE ALLEGED ISSUE WAS NO RESOLVED THROUGH A BLOOD RETEST. REPLACEMENT PRODUCTS WERE 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 ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3072045

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening