BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 6751023 · Received July 28, 2017

    Report

    Report Number
    1823260-2017-01562
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    July 8, 2017
    Report Date
    August 3, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE WHERE A BLOCKED TUBING CONNECTOR WAS IDENTIFIED. THIS TUBING CONNECTOR WAS CLOSE TO THE VACUUM TANK WHICH CAUSED VACUUM PROBLEMS ON THE RINSE UNIT. THE BLOCKAGE WAS CLEARED. THE CUSTOMER HAS HAD NO FURTHER ISSUES WITH PHOS2 OR CREJ2 SINCE THE SERVICE VISIT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 2 PATIENT SAMPLES TESTED FOR EITHER PHOS2 PHOSPHATE (INORGANIC) VER.2 (PHOS2) OR CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) ON A COBAS 6000 C (501) MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL PHOS2 RESULT WAS 0.36 MMOL/L. THE REPEAT RESULT WAS 0.78 MMOL/L. PATIENT 2 INITIAL CREJ2 RESULT WAS 39.8 UMOL/L. THE REPEAT RESULT WAS 94.0 UMOL/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE PHOS2 REAGENT LOT NUMBER WAS 225845. THE EXPIRATION DATE WAS NOT PROVIDED. THE CREJ2 REAGENT LOT NUMBER WAS 241895. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531060 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1