BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 17270041 · Received July 6, 2023

    Report

    Report Number
    1823260-2023-02189
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    March 4, 2023
    Report Date
    July 6, 2023
    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 REAGENT LOT NUMBER IS 717259. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER CHANGED THE WATER TANK, WATER FILTERS, SAMPLE, REAGENT PROBES, AND REACTION VESSELS; AND RAN THE CALCIUM ASSAYS IN DUPLICATE AFTER QUESTIONABLE RESULTS WERE NOTED ON 04-JUN-2023. THE FIELD SERVICE ENGINEER (FSE) CHANGED THE GEAR PUMP HEAD (GPH). IT IS RECOMMENDED THAT THE GPH BE REPLACED WHEN ITS OPERATING HOURS HAVE EXCEEDED 5000 HOURS. THE FSE ALSO CHECKED THE HORIZONTAL AND VERTICAL ULTRASONIC MIXER (USM) ALIGNMENTS. HE CHANGED THE BLACK TANK AND CLEANED THE BATH, DRAIN AND USM. HE ALSO CHECKED THE WASH LEVELS AND VERIFIED THAT THE GPH PRESSURE WAS WITHIN SPECIFICATIONS. HE ALSO CHANGED ALL THE PROBES. HE CONFIRMED THE ASSAY AND MODULE WERE PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION EXCLUDED REAGENT ISSUES, AS NO FURTHER CASES WERE REPORTED AND CORRECT RERUNS WERE PERFORMED WITH THE SAME REAGENT. THE INVESTIGATION DETERMINED THAT THE EVENT WAS DUE TO A SERVICE MAINTENANCE-RELATED 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 QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FROM OVER 245 PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. THE REPORTER STATED THAT THEY HAVE AN ONGOING ISSUE WITH THE CALCIUM RESULTS. THE REPORTER STATED THAT QUESTIONABLE HIGH RESULTS WERE NOTED ON APPROXIMATELY FOUR OCCASIONS OVER THE PAST THREE TO FOUR WEEKS AND SEEMED TO BE ISOLATED IN LINE 1 OF THE MODULE. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT RESULTS: THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE 1 THE INITIAL RESULT WAS 1.79 MMOL/L. THE REPEAT RESULT WAS 2.4 MMOL/L. SAMPLE 2 THE INITIAL RESULT WAS 1.83 MMOL/L. THE REPEAT RESULT WAS 2.33 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989786 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown