BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1971853 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00480
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 11, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE EVENT DID NOT IDENTIFY A SPECIFIC ROOT CAUSE. ASSAY PERFORMANCE CHECKS WERE PERFORMED AND WITHIN SPECIFICATION. CALIBRATION AND QUALITY CONTROLS WERE ALSO WITHIN SPECIFICATION. IT WAS NOTED THE MESSAGE HISTORY DID NOTIFY THE USER LIQUID FLOW CLEANING WAS RECOMMENDED PRIOR TO WHEN THE DISCREPANT RESULTS WERE RECEIVED. IN ADDITION, IT WAS IDENTIFIED THE CUSTOMER IS USING 13MM SAMPLE TUBES WITHOUT USING RECOMMENDED RACK ADAPTERS AND THE CUSTOMER IS USING A SAMPLE CENTRIFUGATION TIME THAT IS TOO SHORT. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE GENERATION 2 (PRO BNP) RESULTS FOR THREE PATIENT SAMPLES, OF WHICH ONE WAS DISCREPANT. THE INITIAL RESULT WAS 8.12 PG/ML AND THE REPEAT RESULT OF (B)(6) 2011 WAS 367.4 PG/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE PRO BNP REAGENT LOT NUMBER WAS 15712305. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SYSTEM REQUIRED LIQUID FLOW PATH CLEANING AND THE CUSTOMER PERFORMED LIQUID FLOW PATH CLEANING MAINTENANCE. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTS WITH NORMAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR