BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2060372 · Received April 15, 2011

    Report

    Report Number
    2939301-2011-03137
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    April 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON AUGUST 9, 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A CRACKED/ BROKEN LCD. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER HAS A CRACKED DISPLAY AND A PURPLE WITH BLACK MARKS IN THE BACKGROUND OF THE DISPLAY. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2011. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH AN INSULIN PUMP. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED SHE CONTINUED TO ADMINISTER HER DOSES OF LANTUS AND HUMALOG REGULAR INSULIN (DOSES NOT KNOWN) AS USUAL. ACCORDING TO THE CCA DOCUMENTATION, THE PATIENT DENIED DEVELOPING SYMPTOMS. HOWEVER, ON (B)(6) 2011 AT 8:00 AM, THE PATIENT REPORTED GOING TO URGENT CARE/CLINIC FOR ASSISTANCE. AT THE TIME OF THE URGENT CARE/CLINIC, THE PATIENT INDICATED THEY TREATED HER WITH INTRAVENOUS (IV) FLUIDS FOR HIGH BLOOD SUGAR SYMPTOMS. THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER AND THE METER WAS NOT MISUSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3061710

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention