BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 6854683 · Received September 11, 2017

    Report

    Report Number
    1823260-2017-01942
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 21, 2017
    Report Date
    September 11, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ACETA ACETAMINOPHEN RESULT FOR ONE PATIENT SAMPLE. THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR ACETAMINOPHEN INTOXICATION. THE PROCEDURE AT THE SITE WAS TO TEST FOR ACETAMINOPHEN FIVE TIMES FROM SAMPLES DRAWN AT DIFFERENT TIMES. THE RESULT FOR THE SECOND SAMPLE IN THE SERIES AT 20:54 WAS 5.3 UG/ML AND WAS REPORTED OUTSIDE THE LABORATORY. BASED ON THIS RESULT, AN ACETYLCYSTEINE INFUSION WAS STOPPED. AFTER THE RESULT FOR THE THIRD SAMPLE DRAWN WAS 99.9 UG/ML, THE PHYSICIAN CONTACTED THE LABORATORY. THE ACETYLCYSTEINE INFUSION WAS RESTARTED. ON (B)(6) 2017, THE SECOND SAMPLE IN THE SERIES WAS REPEATED AND THE RESULT WAS 167.1. UG/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT WAS IN STABLE CONDITION AND THE LIVER AND KIDNEY FUNCTIONS APPEARED TO RECOVER. THE REAGENT LOT NUMBER WAS 173776 WITH AN EXPIRATION DATE OF 31-JAN-2018. REVIEW OF THE PROVIDED ANALYZER ALARM TRACE FROM AROUND TIME OF EVENT HAD ABNORMAL ASPIRATION ALARMS. CALIBRATION PRIOR TO THE EVENT AND QC ON THE DATA OF THE EVENT WAS ACCEPTABLE. FURTHER INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. SINCE CALIBRATION AND QC DATA WERE ACCEPTABLE, A GENERAL ISSUE WITH THE REAGENT OR INSTRUMENT COULD BE EXCLUDED. THE ROOT CAUSE WAS MOST LIKELY DUE TO INCORRECT USE OF THE 12X75 MM SAMPLE TUBE WITHOUT A SAMPLE TUBE RACK ADAPTER. PRODUCT LABELING FOR THE ANALYZER STATES "TAKE SPECIAL CARE TO PLACE SAMPLE TUBES CORRECTLY ON THE RACK. THIS IS ESPECIALLY IMPORTANT FOR 13 MM TUBES WHICH ARE NARROWER AND MORE LIKELY TO TILT IF PLACED INCORRECTLY. IF THE TUBES ARE NOT CORRECTLY SEATED IN AN UPRIGHT POSITION ON THE RACK, THE SAMPLE PROBE MAY ATTEMPT TO SAMPLE OUTSIDE THE TUBE. OR THE SAMPLE PROBE MAY HIT THE SIDE OF THE TUBE, CAUSING ERRORS AND INCORRECT RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635910 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C502 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR