BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 7225183 · Received January 29, 2018

    Report

    Report Number
    1823260-2018-00259
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 9, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DURING A REVIEW OF THE ALARM TRACE, THERE WERE MANY ABNORMAL SAMPLE ALARMS. THE INVESTIGATION DETERMINED THAT THE ERRONEOUS RESULTS WERE RELATED TO SAMPLE QUALITY DUE TO PRE-ANALYTIC ISSUES AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS LOW RESULTS FOR 3 PATIENT SAMPLES TESTED FOR HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION (HDLC3) ON A COBAS 8000 C 702 MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL HDLC3 RESULT WAS 5.7 MG/DL. THE REPEAT RESULT WAS 38.3 MG/DL. PATIENT 2 INITIAL HDLC3 RESULT WAS 17.6 MG/DL. THE REPEAT RESULT WAS 72.2 MG/DL. PATIENT 3 INITIAL HDLC3 RESULT WAS 2.5 MG/DL. THE REPEAT RESULT WAS 39.3 MG/DL. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HDLC3 REAGENT LOT NUMBER WAS 242363 WITH AN EXPIRATION DATE OF 31-MAR-2019. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND CHANGED THE SAMPLE AND REAGENT PROBES, THE SAMPLE BOARD AND CLEANED THE FLUID LINE WITH BLEACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68383 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1