BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 15632836 · Received October 19, 2022

    Report

    Report Number
    1823260-2022-03252
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 22, 2022
    Report Date
    December 2, 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 INVESTIGATION EXCLUDED REAGENT ISSUES. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.  THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.  THE INVESTIGATION DETERMINED THE EVENT WAS RELATED TO A MAINTENANCE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED A PRECISION TEST WITH ACCEPTABLE RESULTS. THE FIELD SERVICE ENGINEER (FSE) REPLACED ONE OF THE SAMPLE AND REAGENT PROBES. HE MADE ADJUSTMENTS WITH ATTENTION TO THE WASHING. HE ADJUSTED THE GEAR PUMP HEAD (GPH) AND THE MAIN WATER PUMP PRESSURES WHICH HE NOTED TO BE TOO HIGH. HE ALSO NOTED THAT THE PHOTOMETER READING WAS TOO HIGH SO HE CHANGED THE HEAT-CUT FILTER. HE ALSO REPLACED THE LENS WHICH WAS NOTED TO BE SCRATCHED. THE CUSTOMER PERFORMED CALIBRATIONS AND QC. THE CUSTOMER MONITORED THE PERFORMANCE OF THE MODULE. THEY STILL OBTAINED OUT-OF-RANGE INITIAL QC RESULTS THAT WOULD BE IN RANGE UPON RERUN. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE PHOS2 PHOSPHATE (INORGANIC) VER.2 RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL PHOSPHATE RESULT WAS 1.13 MMOL/L. THE REPEAT RESULT WAS 1.93 MMOL/L. THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2945668 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown