BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 11965313 · Received June 9, 2021

    Report

    Report Number
    1823260-2021-01699
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 9, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) # (B)(4). THIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE REPRESENTATIVE FOUND THE GEAR PUMP PRESSURE WAS LOW. THE GEAR PUMP HEAD (GPH) HAD NOT BEEN REPLACED AFTER 5,000 HOURS OF OPERATION AND IS CURRENTLY BEING USED FOR APPROXIMATELY 26,622 HOURS OF OPERATION. HE CHECKED THE OUTSIDE WASHING PRESSURE ON THE PROBE AND THE CELL RINSE WATER PRESSURE. HE REPLACED THE SAMPLE PROBE AND CHECKED AND ALIGNED ALL THE PROBES. PRECISION CHECKS PASSED AND NO FURTHER ISSUES WERE OBSERVED AFTER SERVICE WAS PERFORMED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HBA1C III TINA-QUANT HEMOGLOBIN A1C III RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. PATIENT (B)(6): THE INITIAL RESULT WAS 5.6% AND THE REPEATED RESULTS WERE 6.51% AND 6.51%. THE FIRST REPEATED RESULT WAS PERFORMED ON A DIFFERENT C501 MODULE AND THE SECOND REPEATED RESULT WAS PERFORMED ON THE SAME C501 MODULE AS THE INITIAL RESULT. PATIENT (B)(6): THE INITIAL RESULT WAS 7.6% AND THE REPEATED RESULTS WERE 8.94% AND 8.88%. THE FIRST REPEATED RESULT WAS PERFORMED ON A DIFFERENT C501 MODULE AND THE SECOND REPEATED RESULT WAS PERFORMED ON THE SAME C501 MODULE AS THE INITIAL RESULT. PATIENT (B)(6): THE INITIAL RESULT WAS 4.5% AND THE REPEATED RESULTS WERE 4.97% AND 5.17%. THE FIRST REPEATED RESULT WAS PERFORMED ON A DIFFERENT C501 MODULE AND THE SECOND REPEATED RESULT WAS PERFORMED ON THE SAME C501 MODULE AS THE INITIAL RESULT. FOR ALL 3 PATIENTS: THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED AS PART OF A COMPARISON BETWEEN TWO C501 MODULES. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE REAGENT LOT NUMBER WAS 52045801. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861191 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1