BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2241716 · Received September 9, 2011

    Report

    Report Number
    2939301-2011-08759
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT APPROXIMATELY 4PM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE AND ALSO DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. APPROXIMATELY SEVEN HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF SHAKING, DIZZINESS, SWEATING, AND FELL. ACCORDING TO THE CSR'S DOCUMENTATION, AT THE ONSET OF HER SYMPTOMS, THE PATIENT'S DAUGHTER ADMINISTERED TREATMENT BY GIVING HER GLUCOSE TABLETS/GLUCOSE GEL. DURING TROUBLESHOOTING, THE CSR NOTED THAT THERE WAS MISUSE OF THE LFS PRODUCT; THE SUBJECT METER REPORTEDLY GOT WET WITH WATER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT WAS NOTED THAT THE SUBJECT METER WAS EXPOSED TO WATER AND GOT WET, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY 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. 3140383

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R