BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02030

    MDR report key: 6882143 · Received September 21, 2017

    Report

    Report Number
    1823260-2017-02030
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    April 7, 2017
    Report Date
    February 19, 2018
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. AS CALIBRATION, QC, AND PRECISION DATA WAS ACCEPTABLE, A PREANALYTIC ISSUE WAS SUSPECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ONGOING ISSUE WITH LOW UREAL UREA/BUN RESULTS THAT UPON REPEAT TESTING ON ANOTHER ANALYZER WOULD BE NORMAL. OF THE DATA PROVIDED FOR SEVEN PATIENT SAMPLES, ONLY THE RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL RESULT WAS 0.54 MMOL/L AND THE REPEAT RESULT WAS 15.06 MMOL/L. PATIENT 2 ON (B)(6) 2017, THE INITIAL RESULT WAS 2.25 MMOL/LAND THE REPEAT RESULT WAS 25.80 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WERE LATER AMENDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO OTHER ASSAYS WERE AFFECTED. THE REAGENT LOT IN USE FOR PATIENT 1 WAS 181348 AND THE REAGENT LOT IN USE FOR PATIENT 2 WAS 212533. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. ALL OF THE SAMPLE PROBES AND RINSE TUBINGS WERE REPLACED. A PRECISION CHECK AND ACCUMULATIVE QC PERFORMANCE WAS ACCEPTABLE. ALL RINSE WATER LEVELS, VACUUMS, SAMPLE AND REAGENT PROBE ALIGNMENTS, AND SAMPLE QUALITY WERE CHECKED AND FOUND TO BE ACCEPTABLE. IT WAS SUSPECTED THE ISSUE WAS DUE TO CRYSTALS FROM THE DETERGENT USED FOR CLEANING THE SYSTEM. THE FIELD SERVICE REPRESENTATIVE PERFORMED PREVENTIVE MAINTENANCE AND FOUND A FEW CRYSTALS AROUND THE ULTRASONIC MIXER (USM).

    Patients

    Seq Age Sex Outcome Treatment
    1