BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2221158 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-07065
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    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

    THE PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH HER ONE TOUCH ULTRALINK METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011 AT 5:30 AM. THE PATIENT OBTAINED A READING OF "254 MG/DL" ON THE SUBJECT METER, WHICH SHE FELT WAS INACCURATE HIGH COMPARED TO HER FEELINGS/ NORMAL VALUES. SHE DENIED TAKING ANY MEDICATIONS TO MANAGE HER DIABETES. DUE TO THE INACCURATE HIGH RESULT, AT AN UNSPECIFIED TIME "RIGHT AFTER THE READING", SHE TOOK A BOLUS OF 5U OF INSULIN. THE PATIENT CLAIMED 25 MINUTES LATER, AFTER THE PRODUCT ISSUE BEGAN, SHE FELT SHAKY. IT IS UNKNOWN IF IN RESPONSE TO HER SYMPTOMS SHE RECEIVED ANY FORM OF MEDICAL TREATMENT. NO OTHER DEVICE WAS AVAILABLE AT THE TIME OF CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE. WHILE TROUBLESHOOTING THE CONTROL SOLUTION TEST WAS NOT PERFORMED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3148103

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening