BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2544240 · Received April 23, 2012

    Report

    Report Number
    1823260-2012-02088
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 31, 2012
    Report Date
    April 23, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) POTASSIUM, ISE CHLORIDE, ALBUMIN GEN.2 (ALB), AND TOTAL PROTEIN GEN.2 (TP) RESULTS ON THEIR C501 ANALYZER. THE CUSTOMER PROVIDED DATA FOR THREE PATIENTS, OF WHICH TWO PATIENTS HAD DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE NIGHT SHIFT DISCOVERED THE SAMPLE PROBE DID NOT SEEM TO BE SENSING THE LIQUID LEVEL. THE CUSTOMER PERFORMED A SAMPLE PROBE AIR PURGE AND OBSERVED A STEADY STREAM OF LIQUID BEING DISPENSED. THE CUSTOMER THEN PERFORMED THE WEEKLY MAINTENANCE AND PIPE. THE FIRST PATIENT'S INITIAL ALB RESULT WAS 0.3 G/DL. THE DOCTOR CALLED TO QUESTION THE SAMPLE. THE CUSTOMER EXAMINED THE SAMPLE, REMOVED A FIBRIN CLOT, AND REPEATED THE SAMPLE ON THE SAME ANALYZER. THE REPEAT RESULT WAS 3.4 G/DL. THE SECOND PATIENT, A (B)(6) FEMALE, HAD AN INITIAL POTASSIUM RESULT OF 5.26 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 4.1 MMOL/L. THE SECOND PATIENT'S INITIAL CHLORIDE RESULT WAS 138.0 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 102 MMOL/L. THE SECOND PATIENT'S INITIAL TP RESULT WAS 8.1 G/DL. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS 6.7 G/DL THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE CORRECT AND THEY WERE ISSUED AS CORRECTED REPORTS. THERE WERE NO ADVERSE EVENTS. THE POTASSIUM ELECTRODE LOT NUMBER WAS T04 AND THE EXPIRATION DATE WAS (B)(6) 2012. THE CHLORIDE ELECTRODE LOT NUMBER WAS X34 AND THE EXPIRATION DATE WAS (B)(6) 2012. THE ALB REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE TP REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND AN ELECTRONIC FAILURE; THE SAMPLE MECHANISM LIQUID LEVEL DETECTOR (LLD) PRINTED CIRCUIT BOARD (PCB) WAS MALFUNCTIONING. HE INSTALLED A REPLACEMENT SAMPLE MECHANISM LLD PCB. HE PERFORMED A PRECISION TEST WITH RESULTS MEETING THE CUSTOMER'S EXPECTATIONS. HE RELEASED THE ANALYZER TO THE CUSTOMER FOR PATIENT TESTING OPERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1