BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 14842530 · Received June 28, 2022

    Report

    Report Number
    1823260-2022-01883
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 28, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND THE RINSE TUBING TO BE OK. HE FOUND THE CELL LEVELS WERE LOW, THE GEAR PUMP PRESSURE WAS LOW, SAMPLE PROBES WERE NOT POSITIONED IN THE WASH FLOW, AND THE WATER RESERVOIR WAS DIRTY. HE ADJUSTED THE SAMPLE PROBES AND PERFORMED SYSTEM CLEANING. HE VERIFIED THE GEAR PUMP PRESSURE AND THE CELL LEVELS WERE OK. HE PERFORMED A CELL BLANK MEASUREMENT, PRECISION CHECK, ISE CHECK, PHOTOMETER CHECK, AND QC WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR ONE PATIENT ON A COBAS 8000 C 702 MODULE. THE PATIENT'S INITIAL CREATININE WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE SAMPLE. THE PATIENT'S INITIAL CREATININE RESULT WAS 338 UMOL/L. THE PATIENT'S REPEAT CREATININE RESULT WAS 43 UMOL/L. THE CREATININE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813717 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown