BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 23201272 · Received October 2, 2025

    Report

    Report Number
    1823260-2025-04037
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 10, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REAGENT ISSUE CAN BE EXCLUDED AS THE CORRECT RERUN WAS PERFORMED USING THE SAME REAGENT. A REVIEW OF THE REACTION DATA SHOWED THAT THE REACTION HAD ALMOST NO ANALYTE NOR SAMPLE. A ROCHE FIELD SPECIALIST DETERMINED THE CUSTOMER WAS USING A MICRO-CUP ON TOP OF A TUBE INCORRECTLY. THE CUSTOMER WAS INSTRUCTED ON CORRECT USE OF MICRO-CUPS. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH AN INCORRECT USAGE OF MICRO-CUPS.

    Additional Manufacturer Narrative · 0

    THE TOTAL BILIRUBIN REAGENT LOT NUMBER WAS 828830, THE DIRECT BILIRUBIN REAGENT LOT NUMBER WAS 851830, AND THE CRP REAGENT LOT NUMBER WAS 832963. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO NEONATE PATIENT SAMPLES TESTED ON A COBAS 6000 C501 MODULE. RESULTS FROM THE FOLLOWING ASSAYS WERE AFFECTED: BILIRUBIN TOTAL GEN.3, BILIRUBIN DIRECT GEN.2, AND CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE. THE SAMPLES WERE PROCESSED IN MICRO-CUP ON TOP OF A TUBE. NO QUESTIONABLE RESULTED WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A CRP VALUE OF 0.000 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A CRP VALUE OF > 6.065 MG/DL WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED THE SECOND ANALYZER USING DECREASED SAMPLE VOLUME, RESULTING IN A CRP VALUE OF 4.938 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES ON (B)(6) 2025: DIRECT BILIRUBIN = 0.13 MG/DL, TOTAL BILIRUBIN = 0.53 MG/DL. THE SAMPLE WAS REPEATED ON A THIRD ANALYZER ON (B)(6) 2025, RESULTING IN THE FOLLOWING VALUES: DIRECT BILIRUBIN = 0.50 MG/DL, TOTAL BILIRUBIN = 11.32 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313119 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown