BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 7070094 · Received November 30, 2017

    Report

    Report Number
    1823260-2017-02782
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 14, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS LOW RESULT FOR A NEWBORN PATIENT SAMPLE TESTED FOR BILT3 BILIRUBIN TOTAL GEN.3 (BILT3) ON A COBAS 6000 C (501) MODULE. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL BILT3 RESULT FROM A SAMPLE IN A MICRO CUP WAS 0.27 MG/DL. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 17.59 MG/DL AND 17.83 MG/DL. THE CUSTOMER STATED THE SAMPLE DID NOT HAVE FOAM OR BUBBLES. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE BILT3 REAGENT LOT NUMBER WAS 252669. THE EXPIRATION DATE WAS NOT PROVIDED. UPON REVIEW OF THE REACTION MONITOR, THE REACTION CURVE SHOWS STRONGLY FLUCTUATING ABSORBANCE VALUES FOR THE INITIAL RESULT OF 0.27 MG/DL. THE REPEAT RESULT OF 17.59 MG/DL SHOWS A SMOOTH, NON-FLUCTUATING REACTION CURVE WHICH PRODUCED THE CORRECT RESULT. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE, CALIBRATION, QUALITY CONTROL DATA OR SAMPLE TUBE HANDLING. BASED ON THE INFORMATION PROVIDED, THE ERRONEOUS LOW RESULT WAS DUE TO A MICRO-CLOT OR FIBRIN STRAND IN THE SAMPLE. THE REACTION MONITOR SHOWS FLUCTUATING ABSORBANCE VALUES AND THAT AN INSUFFICIENT SAMPLE VOLUME WAS PIPETTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850162 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1