BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 19536856 · Received June 14, 2024

    Report

    Report Number
    1823260-2024-01760
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND FOUND THE GEAR PUMP HEAD (GPH) PRESSURE LOW AND THE REAGENT PROBE CONTAMINATED. HE THEN REPLACED THE GPH AND THE REAGENT PROBE. HE PERFORMED A REPEATABILITY REST AND TEST RUNS WHICH INDICATED THE MODULE WAS PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION EXCLUDED REAGENT ISSUES AS NO FURTHER CASES WERE REPORTED AND A CORRECT RERUN WAS PERFORMED USING THE SAME REAGENT. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREATININE RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR COMPLAINED THAT THE RESULT DID NOT MATCH THE PATIENT'S HISTORY PROMPTING THE RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2024: THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 2.72 MG/DL. ON (B)(6) 2024: THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 1.09 MG/DL. THE RESULT OF A NEW PATIENT SAMPLE WAS 1.03 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183843 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown