BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 7215207 · Received January 24, 2018

    Report

    Report Number
    1823260-2018-00216
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 14, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4)

    Additional Manufacturer Narrative · 1

    THE CORRECT ANTI-TPO REAGENT LOT NUMBER WAS 220849. VARIATION IN CALIBRATION SIGNALS AND UNSTABLE INTERNAL QC RECOVERY WERE OBSERVED FOR THE TEST ON THE AFFECTED ANALYZER. NO FURTHER ISSUES OCCURRED AFTER THE SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE ENGINEER. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (ANTI-TPO) ON A COBAS 8000 E 801 MODULE (E801). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 28 IU/ML. THE SAMPLE WAS REPEATED ON A SECOND E801 ANALYZER, RESULTING AS 56 IU/ML. A HIGHER VALUE WAS EXPECTED FROM THE PATIENT, SO THE VALUE OF 56 IU/ML FIT WITHIN THE CLINICAL EXPECTATIONS FOR THIS PATIENT. THE CUSTOMER RE-CALIBRATED THE TEST AND THEN REPEATED THE SAMPLE ON THE ORIGINAL E801 ANALYZER, RESULTING AS 38 IU/ML. THE CUSTOMER REPLACED THE REAGENT PACK, PREPARED FRESH CALIBATORS AND CONTROL MATERIAL, THEN REPEATED THE SAMPLE ON THE ORIGINAL E801 ANALYZER. CONTROLS WERE WITHIN RANGE, BUT THE PATIENT SAMPLE AGAIN RECOVERED IN THE RANGE OF 20 - 40 IU/ML. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE ANTI-TPO REAGENT LOT NUMBER WAS 249095. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED A DAMAGED MEASURING CELL ON THE ANALYZER. HE RAN TEST RUNS AND VERIFIED PROPER FUNCTIONING OF THE ANALYZER. HE ALSO OBSERVED AN ISSUE WITH THE ANALYZER WATER SUPPLY DUE TO WATER PRESSURE ISSUES IN THE CUSTOMER'S LABORATORY. THE ANALYZER WAS NOT SUFFICIENTLY WASHING AND PRIMING DURING THE SAMPLE RUN, WHICH MAY HAVE CAUSED THE INCORRECT MEASUREMENT. NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER AFTER THESE SERVICE ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59599 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1