BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3021441 · Received March 26, 2013

    Report

    Report Number
    1823260-2013-01844
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    July 23, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. AN INVESTIGATION ON THREE DIFFERENT C501 ANALYZERS DEMONSTRATED THERE WAS NO CARRY-OVER FROM CRP TO CALCIUM ON THE ANALYZER. ISOLATED ANALYZERS IN THE FIELD MIGHT EXPERIENCE CARRY-OVER IF THE ANALYZER MAINTENANCE IS NOT PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CALCIUM GEN.2 (CA) RESULTS ON THEIR C501 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENTS, FOUR OF WHICH HAD DISCREPANT RESULTS. THE CUSTOMER STATED THE FIRST THREE PATIENTS' INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. A SHORT WHILE LATER, THE CUSTOMER CALLED THE PHYSICIAN AND SAID THE INITIAL RESULTS WERE INCORRECT. IT WAS UNKNOWN IF THE FOURTH PATIENT'S INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE FIRST PATIENT'S INITIAL CA RESULT WAS 3.63 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 2.12 MMOL/L. THE SECOND PATIENT'S INITIAL CA RESULT WAS 3.27 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 2.27 MMOL/L. THE THIRD PATIENT'S INITIAL CA RESULT WAS 3.60 MMOL/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 2.49 MMOL/L. THERE WAS NO MEDICAL INTERVENTION FOR THE FIRST THREE PATIENTS AND THEY WERE NOT HARMED OR AFFECTED BY THIS EVENT. ON (B)(6) 2013, THE FOURTH PATIENT'S INITIAL CA RESULT WAS 0.26 MMOL/L ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 2.29 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER, AND THE RESULT WAS 2.31 MMOL/L. IT WAS UNKNOWN IF THE FOURTH PATIENT WAS ADVERSELY AFFECTED BY THIS EVENT. THE CA REAGENT LOT NUMBER WAS 659936 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DECONTAMINATED THE ANALYZER, CHECKED THE TUBING FOR CRACKS, AND CLEANED THE SAMPLE NEEDLE. THE CUSTOMER INSTALLED WASHING STEPS FROM ALL TESTS TO CA ON ALL NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123859 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1