BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2910079 · Received January 11, 2013

    Report

    Report Number
    1823260-2013-00239
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE SAME PATIENT SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR ISE CHLORIDE. THE SAMPLE INITIALLY RESULTED AS 90.6 MMOL/L ACCOMPANIED BY A DATA FLAG FOR ISE CHLORIDE. THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AS 91 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON C501 ANALYZER SERIAL NUMBER (B)(4) RESULTING AS 104 MMOL/L. THE VALUE OF 104 MMOL/L WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED FOR THIS VALUE. THE INITIAL ISE SODIUM VALUE OF 118 MMOL/L WAS ACCOMPANIED BY A DATA FLAG. THE PATIENT AGE AND GENDER HAVE BEEN UPDATED ON SECTION A OF THE FORM. THE PATIENT HAD AN ISE SODIUM RESULT OF 129 MMOL/L AND AN ISE CHLORIDE RESULT OF 97 MMOL/L ON (B)(6) 2012. THE PATIENT HAD AN ISE SODIUM RESULT OF 131 MMOL/L AND AN ISE CHLORIDE RESULT OF 103 MMOL/L (B)(6) 2012. THE PATIENT HAD AN ISE SODIUM RESULT OF 131 MMOL/L AND AN ISE CHLORIDE RESULT OF 104 MMOL/L ON (B)(6) 2013.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR QUALITY CONTROLS FOR ION SELECTIVE ELECTRODE (ISE) TESTS WERE OUT OF RANGE. THE CUSTOMER ATTEMPTED TO CALIBRATE, BUT RECEIVED ERRORS. THE CUSTOMER THEN REPLACED ALL ISE ELECTRODES, PRIMED REAGENTS, THEN RAN 10 DUMMY SERUM SAMPLES PRIOR TO RECALIBRATING. AFTER OBTAINING A VALID CALIBRATION, A FEW OF THE CONTROLS WERE STILL OUT OF RANGE. WHEN ASKED ABOUT PATIENT RESULTS, THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE HAD AN ERRONEOUS RESULT FOR ISE SODIUM. THE SAMPLE INITIALLY RESULTED AS 118 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN REQUESTED A REDRAW OF THE PATIENT AND THIS SAMPLE WAS RUN ON A DIFFERENT C501 ANALYZER, SERIAL NUMBER (B)(4), RESULTING AS 131 MMOL/L. THE ORIGINAL SAMPLE WAS THEN REPEATED ON C501 ANALYZER, SERIAL NUMBER (B)(4), RESULTING AS 131 MMOL/L WHICH WAS CONSIDERED TO BE THE CORRECT RESULT. THE CUSTOMER DID INDICATE THAT CONTROLS WERE WITHIN RANGE PRIOR TO RUNNING THIS PATIENT SAMPLE. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OR EXPIRATION DATE FOR THE ISE SODIUM ELECTRODE. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A HOLE IN THE CELL RINSE MECHANISM TUBING. HE REPLACED THE CELL RINSE MECHANISM TUBING AND RE-CONNECTED ALL CELL VACUUM TUBING. HE RAN ISE CHECKS AND MECHANISM CHECKS, THE SYSTEM WAS RUNNING WITHIN SPECIFICATION. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS AND ALL WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16277 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR