BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 15831281 · Received November 20, 2022

    Report

    Report Number
    1823260-2022-03689
    Event Type
    Malfunction
    Date Received
    November 20, 2022
    Date of Event
    November 1, 2022
    Report Date
    December 9, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630920587
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER DETERMINED THAT A REAGENT NOZZLE TUBING WAS DEFORMED AND A SOLID CONNECTION WAS NOT BEING MADE. THIS ALLOWED WATER TO DRIP PAST THE CONNECTOR. THE TUBING WAS REMOVED AND THE END WAS RE-FLARED. AIR PURGES AND MECHANISM CHECKS WERE PERFORMED. THE TUBE WAS SEATED PROPERLY AND THERE WAS NO WATER DRIPPING FROM THE CONNECTION. CALIBRATION AND CONTROLS WERE SUCCESSFUL. MICROALBUMIN CONTROL RECOVERY WAS THE SAME AS IT WAS ON A SECOND ANALYZER.

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION PERFORMED ON (B)(6) 2022 WAS OK AND THERE WERE NO ALARMS. ONE LEVEL OF CONTROL WAS OUTSIDE OF RANGE FOUR TIMES PRIOR TO RECEIVING RESULTS THAT RECOVERED WITHIN RANGE PRIOR TO THE EVENT. THE SECOND LEVEL OF CONTROL WAS ACCEPTABLE PRIOR TO THE EVENT. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH PATIENT SAMPLE RECOVERY FOR ALBT2 TINA-QUANT ALBUMIN GEN.2 ON THE COBAS 6000 C (501) MODULE. THE FIELD SERVICE ENGINEER HAD BEEN OUT TWICE TO ADDRESS THE ISSUE AND ALL PROBES WERE CHANGED ON ONE OF THE VISITS. THE CUSTOMER STATED THE ISSUE SEEMED TO START AFTER USING A NEW LOT OF CALIBRATOR. DATA WAS PROVIDED FOR 5 PATIENT SAMPLES TESTED FOR MICROALBUMIN. THE INITIAL VALUES WERE MEASURED EITHER ON (B)(6) 2022 OR(B)(6)2022 AND WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON (B)(6)2022. THE CUSTOMER DID NOT KNOW WHICH VALUES WERE CORRECT. THE CUSTOMER STATED THAT THE FIRST TWO SAMPLES WERE TESTED PRIOR TO THE VISITS FROM THE ENGINEER. SAMPLES 3-5 WERE TESTED AFTER THE VISITS FROM THE ENGINEER. THE FIRST SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF < 12 MG/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 22 MG/L. THE SECOND SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 106.3 MG/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 22.1 MG/L. THE THIRD SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF < 12 MG/L WITH A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 38.9 MG/L. THE FOURTH SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 15.9 MG/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 25.9 MG/L. THE FIFTH SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 1181 MG/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN A VALUE OF 595.5 MG/L WITH A DATA FLAG AND 802.8 MG/L. THE MICROALBUMIN REAGENT LOT NUMBER WAS 65268801, WITH AN EXPIRATION DATE OF 30-APR-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615175 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA 04015630920587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown