BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 6934762 · Received October 10, 2017

    Report

    Report Number
    1823260-2017-02239
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE FOUND THE RINSE STATION TUBE WAS SPLIT AND REPAIRED IT. A TEST OF THE SYSTEM, CALIBRATION, AND QC WERE ACCEPTABLE. IT WAS CONFIRMED THAT NO ADDITIONAL ISSUES WERE REPORTED SINCE THE RINSE TUBE WAS REPLACED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER HAD AN ISSUE WITH QC RESULTS AND RECEIVED QUESTIONABLE PATIENT RESULTS FOR CA2 CALCIUM GEN. 2, MAGNESIUM, AND ALBUMIN OVER SEVERAL DAYS. OF THE DATA PROVIDED, ONLY THE CALCIUM RESULTS FOR TWO PATIENT SAMPLES WERE DISCREPANT. THE SAMPLES WERE RETESTED ON ANOTHER COBAS 8000 C 702 MODULE AND THE RESULTS BETTER MATCHED THE CLINICAL PICTURE OF THE PATIENTS. PATIENT 1 INITIAL RESULT WAS 0.69 MMOL/L AND THE REPEAT RESULT WAS 2.43 MMOL/L. ON (B)(6) 2017, PATIENT 2 INITIAL RESULT WAS 0.86 MMOL/L AND THE REPEAT RESULT ON (B)(6) 2017 WAS 1.78 MMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 221425 WITH AN EXPIRATION DATE OF 31-MAY-2017. THE PROVIDED CALIBRATION DATA WAS ACCEPTABLE, BUT THE PROVIDED QC DATA SHOWED A BIAS. REVIEW OF THE PROVIDED ANALYZER ALARM TRACE FOUND FREQUENT ERRORS INDICATING ISSUES WITH THE SAMPLE PIPETTING. AFTER QC WAS OUT OF RANGE, THE CUSTOMER NOTICED CRYSTALLIZATION ON REAGENT. THE REAGENT WAS REPLACED AND THE QC IMPROVED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBES WERE NOT BEING WASHED CORRECTLY AND HE MADE ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715634 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1