BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2260188 · Received September 22, 2011

    Report

    Report Number
    2939301-2011-09406
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Report Date
    September 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S FRIEND OR RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT WAS EXPERIENCING AN "APPLY SAMPLE" MESSAGE EVEN THOUGH THE PATIENT HAD ALREADY APPLIED THE BLOOD SAMPLE ON HER ONE TOUCH ULTRALINK METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011, AT 8:30 PM. THE PATIENT'S REPORTER DENIED THAT THE PATIENT TAKES ANY MEDICATIONS TO MANAGE HER DIABETES AND DUE TO THE ALLEGED ISSUE CONTINUED HER USUAL DIABETES TREATMENT. SHE CLAIMED THAT 7 HRS AFTER THE ALLEGED ISSUE STARTED, AT 3AM, THE PATIENT FELT "STOMACH PAIN" THE PATIENT'S REPORTER DENIED THAT THE PATIENT RECEIVED ANY FORM OF MEDICAL TREATMENT IN RESPONSE TO HER SYMPTOM. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT'S SYMPTOM DID NOT CORRELATE WITH LFS'S DEFINITION SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVED MEDICAL INTERVENTION FOR ACUTE COMPLICATIONS OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3183542

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR