BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 6059907 · Received October 27, 2016

    Report

    Report Number
    1823260-2016-01640
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 27, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR TWO PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE SAMPLE WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE DOCTOR WAS NOTIFIED OF THE QUESTIONABLE RESULTS AND A NEW SAMPLE WAS DRAWN. THE REPEAT RESULTS WERE FROM THE NEW SAMPLE TESTED ON ANOTHER ANALYZER AS THE ORIGINAL SAMPLE DID NOT HAVE A SUFFICIENT AMOUNT OF SAMPLE LEFT TO PERFORM ANY REPEAT TESTING. THE INITIAL CALCIUM RESULT WAS 3.6 MG/DL WITH A DATA FLAG AND THE REPEAT RESULT WAS 9.6 MG/DL. THE INITIAL GLUCOSE RESULT WAS 35 WITH A DATA FLAG AND 36 MG/DL WITH A DATA FLAG AND THE REPEAT RESULT WAS 106 MG/DL. THE INITIAL POTASSIUM RESULT WAS 2.23 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 4.16 MMOL/L. THERE WAS NO ADVERSE EVENT. THE GLUCOSE REAGENT LOT NUMBER WAS 115659. THE CALCIUM REAGENT LOT NUMBER WAS 140411. THE POTASSIUM ELECTRODE LOT NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A FLUIDICS FAILURE AND THE REACTION CELLS WERE ALL FLOODED WITH WATER AND CAUSING CROSS CONTAMINATION. HE PERFORMED A MECHANISM CHECK AND FOUND A NOZZLE ON THE RINSE MECHANISM WAS NOT IN PLACE. HE REPLACED THE NOZZLE HOLDER AND PERFORMED A WATER INCUBATOR EXCHANGE, WASH REACTION PARTS, AND A CELL BLANK MEASUREMENT WHICH WERE ALL OKAY. HE CHECKED THE WATER LEVELS ON THE CUVETTES WHICH WERE OKAY. HE CHECKED THE PROBE ALIGNMENTS AND RINSE LEVELS WHICH WERE ALL OKAY. HE DETERMINED THE ANALYZER WAS WORKING WITHIN SPECIFICATION. THE CUSTOMER PERFORMED QC AND VERIFIED THE RESULTS WERE WITHIN SPECIFICATION. THE FIELD SERVICE REPRESENTATIVE PERFORMED PRECISION TESTING WITH RESULTS WITHIN SPECIFICATION. UPON FOLLOW UP WITH THE CUSTOMER, HE STATED THEY HAVE NOT HAD ANY OTHER ISSUES SINCE SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713393 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO