BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1831328 · Received September 10, 2010

    Report

    Report Number
    2939301-2010-07735
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 28, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 1 MESSAGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE THAT WERE NORMAL WHEN REPEATED ON COBAS C501 ANALYZER SERIAL NUMBER (B)(4). THE SAMPLE WAS PROCESSED BY THE MPA (MODULAR PRE ANALYTIC) AND PLACED INTO A SAMPLE CUP FOR THE INITIAL TESTING. THE REPEAT TESTED WAS PERFORMED FROM THE ORIGINAL SAMPLE TUBE. OF THE DATA PROVIDED, THE RESULTS FOR SODIUM AND POTASSIUM WERE DISCREPANT. THE INITIAL SODIUM RESULT WAS 116 MMOL/L, REPEAT RESULT WAS 138 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 4.40 MMOL/L AND THE REPEAT RESULT WAS 5.20 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE LOT NUMBERS OF THE SODIUM AND POTASSIUM ELECTRODES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND STATED THE ISSUE APPEARED TO BE RELATED TO SAMPLE INTEGRITY. HE CHECKED THE FUNCTIONALITY OF THE RINSING OF THE CELLS AND PROBES AND NOTED THEY APPEARED TO BE FUNCTIONING NORMALLY. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL AND PATIENT SAMPLE WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3001161

    Patients

    Seq Age Sex Outcome Treatment
    1