BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 15235532 · Received August 16, 2022

    Report

    Report Number
    1823260-2022-02460
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 20, 2022
    Report Date
    September 19, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS CHECKED USING A REMOTE CONNECTION. THE DEGASSER, GEAR PUMP HEAD (GPH), SAMPLE PIPETTING, REAGENT PIPETTING, VACUUM, AND WATER QUALITY WERE CHECKED AND NO ISSUES WERE NOTED. ISSUES WERE NOTED IN THE OPTIC, RINSE MECHANISM, AND ULTRASONIC MISSING (USM) TESTS. THE FIELD SERVICE ENGINEER (FSE) REMOVED THE GAUZE FILTER FROM THE MAIN INPUT FEED LINE TO THE MODULE SAMPLE BUFFER (MSB). HE CHECKED THE FILTER AND IT WAS NOTED TO BE CLEAN AND NOT CONTAMINATED. HE REPLACED THE FILTER AND PACKING AS A PROACTIVE MEASURE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IN MFR REPORT REF #1823260-2022-02460-00, H10 - ADDTL MFG NARRATIVE SHOULD HAVE BEEN: "THE INSTRUMENT WAS CHECKED USING A REMOTE CONNECTION. THE DEGASSER, GEAR PUMP HEAD (GPH), SAMPLE PIPETTING, REAGENT PIPETTING, VACUUM, AND WATER QUALITY WERE CHECKED AND NO ISSUES WERE NOTED. ISSUES WERE NOTED IN THE OPTIC, RINSE MECHANISM, AND ULTRASONIC MIXING (USM) TESTS. THE FIELD SERVICE ENGINEER (FSE) REMOVED THE GAUZE FILTER FROM THE MAIN INPUT FEED LINE TO THE MODULE SAMPLE BUFFER (MSB). HE CHECKED THE FILTER AND IT WAS NOTED TO BE CLEAN AND NOT CONTAMINATED. HE REPLACED THE FILTER AND PACKING AS A PROACTIVE MEASURE. THE INVESTIGATION IS ONGOING." INSTEAD OF: "THE INSTRUMENT WAS CHECKED USING A REMOTE CONNECTION. THE DEGASSER, GEAR PUMP HEAD (GPH), SAMPLE PIPETTING, REAGENT PIPETTING, VACUUM, AND WATER QUALITY WERE CHECKED AND NO ISSUES WERE NOTED. ISSUES WERE NOTED IN THE OPTIC, RINSE MECHANISM, AND ULTRASONIC MISSING (USM) TESTS. THE FIELD SERVICE ENGINEER (FSE) REMOVED THE GAUZE FILTER FROM THE MAIN INPUT FEED LINE TO THE MODULE SAMPLE BUFFER (MSB). HE CHECKED THE FILTER AND IT WAS NOTED TO BE CLEAN AND NOT CONTAMINATED. HE REPLACED THE FILTER AND PACKING AS A PROACTIVE MEASURE. THE INVESTIGATION IS ONGOING."

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED EQUIPMENT CHECKS ON THE MODULE. HE CHANGED THE WATER TANK AND PRIMARY WATER FILTERS AT THE SOURCE. HE REMOVED THE GAUZE FILTER FROM THE MAIN INPUT FEED LINE TO THE MODULE SAMPLE BUFFER (MSB) AND CHECKED THE FILTER. THE FILTER WAS NOTED TO BE CLEAN AND NOT CONTAMINATED. HE REPLACED THE FILTER AND PACKING PROACTIVELY. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A MAINTENANCE ISSUE.   AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.  THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE LITHIUM RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, THE INITIAL RESULT WAS 5.17 MMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT USING THE SAMPLE DILUTED ONBOARD WAS 0.35 MMOL/L. THE SECOND REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 0.85 MMOL/L. THE THIRD REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 0.36 MMOL/L. ON (B)(6) 2022, THE SAMPLE WAS SEPARATED OUT OF THE ORIGINAL GEL TUBE. THE FOURTH REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 0.31 MMOL/L. THE FIFTH REPEAT RESULT OF THE SAMPLE DILUTED AT 1:2 WAS 0.30 MMOL/L. A RESULT COULD NOT BE REPORTED ON THIS SAMPLE DUE TO THE INITIAL INCONSISTENCY OF THE RESULTS PRODUCED. A REPEAT SAMPLE HAD TO BE REQUESTED. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916918 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown