BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2212702 · Received August 16, 2011

    Report

    Report Number
    2939301-2011-07472
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    August 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 17, 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE SPC PIN 1 LIFTED HIGH. 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 HIS ONETOUCH ULTRALINK METER WAS DISPLAYING THE APPLY SAMPLE MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. 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 BETWEEN 5:30-6PM. ACCORDING TO THE CSR'S DOCUMENTATION, JUST PRIOR TO THE ALLEGED ISSUE, THE PATIENT REPORTEDLY WOKE UP FROM HIS NAP WITH SYMPTOMS OF "EYES BURNING AND THIRSTY." IT IS NOT KNOWN IF THE PATIENT TESTED WITH THE SUBJECT METER PRIOR TO HIS NAP. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN AND IT IS NOT SPECIFIED IF THE PATIENT TESTED HIS BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE BEGAN. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION OR ADMINISTERING ANY SELF-TREATMENT FOLLOWING THE REPORTED METER ISSUE. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING THE CORRECT TEST STRIPS AND TESTING TECHNIQUE (PER OWNER'S BOOKLET RECOMMENDATION). DURING A RETEST, THE CSR NOTED THAT THE TEST STRIP COMPLETELY DREW IN THE SAMPLE; HOWEVER, THE ALLEGED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR