BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2922522 · Received January 18, 2013

    Report

    Report Number
    1823260-2013-00340
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED TWO QUESTIONABLE CALCIUM RESULTS OVER THE LAST WEEK AND A HALF ON THEIR C501 ANALYZER. THE CUSTOMER WAS ONLY ABLE TO PROVIDE INFORMATION FOR ONE PATIENT THAT HAD A DISCREPANT RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THEY HAVE NOT HAD ANY ISSUES WITH QUALITY CONTROL OR ANY OTHER ASSAYS. THE CUSTOMER DID A PRECISION STUDY WITH ACCEPTABLE RESULTS. THE CUSTOMER STATED THE RINSE MECHANISM APPEARED OK. THE PATIENT'S INITIAL CALCIUM RESULT WAS 4.4 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS AUTO-REPEATED BY THE ANALYZER, BUT THE INITIAL RESULT WAS REPORTED BEFORE THE AUTO-REPEAT WAS COMPLETE. THE REPEAT RESULT WAS 8.0 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS CONSIDERED CORRECT. THERE WERE NO ADVERSE EVENTS. THE CALCIUM REAGENT LOT NUMBER WAS 67085901 AND THE EXPIRATION DATE WAS 04/30/2013. THE FIELD SERVICE REPRESENTATIVE FOUND A FLUIDICS FAILURE. HE OBSERVED A PIN HOLE ON THE VACUUM LINE TO ONE OF THE RINSE NOZZLES. HE REPLACED THE RINSE LINE TO THE RINSE MECHANISM. HE PERFORMED A CHECK TEST AND PRECISION TEST WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27505 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1