BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2518455 · Received April 5, 2012

    Report

    Report Number
    2939301-2012-03380
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    August 13, 2011
    Report Date
    March 19, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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) 2012, THE REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRALINK METER DOES NOT TURN ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY REPORTER THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 3:00PM. THE REPORTER STATED THAT THE PATIENT MANAGES HER DIABETES WITH THE INSULIN PUMP AND TOOK MORE FOOD/DRINK IN RESPONSE TO THE REPORTED ISSUE. TWO DAYS AFTER THE ALLEGED ISSUE OCCURRED, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF "HEADACHES, SHAKES, AND FEELINGS OF LOW" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. THE CCA NOTED THAT THE BATTERIES DID NOT NEED REPLACEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE BEGAN, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3238421

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening