BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1969332 · Received January 24, 2011

    Report

    Report Number
    2939301-2011-00769
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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; 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A CALCODE ISSUE WITH HER ONETOUCH ULTRALINK METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6), 2010 AT AN UNSPECIFIED TIME. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN PUMP. DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED SHE CONTINUED TO TAKE HER USUAL DOSE MEDICATION (TYPE AND DOSE UNKNOWN). THE PATIENT REPORTED SHE WAS EXPERIENCING 'COLD SWEAT', WEAKNESS, AND WAS FEELING AWFUL 2 DAYS AFTER THE ALLEGED ISSUE OCCURRED. IN SPITE OF HER SYMPTOMS, THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO WALK THE PATIENT IN CHANGING THE CODE NUMBER ON THE SUBJECT METER. THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE STILL 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. 3053255

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening