BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1884913 · Received October 28, 2010

    Report

    Report Number
    1823260-2010-06385
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 11, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED WITH THE INFORMATION PROVIDED FOR INVESTIGATION. QUALITY CONTROLS WERE ACCEPTABLE. NO ALARMS WERE GENERATED ON THE SYSTEM. THE PATIENT WAS NOT AFFECTED BY THE EVENT.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA) RESULT FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN UG/L. THE INITIAL RESULT FROM A SERUM SAMPLE WAS 0.057. THE USER HAD SEEN THE PATIENT AND NOTICED HOW ILL HE WAS, SO THE RESULT WAS QUESTIONED AND NOT RELEASED OUTSIDE THE LABORATORY. THE USER REPEATED TESTING ON A HEPARIN SAMPLE FROM THE SAME PATIENT AND THE RESULT WAS >100 WITH A DATA FLAG. THE USER THEN REPEATED TESTING WITH THE SAME SERUM SAMPLE WITH A 1:10 DILUTION. THE RESULT WAS 94.06 AND WAS REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE TPSA REAGENT LOT NUMBER WAS 157638.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, AFTER EXTENDING THE ARRAY INTO THE LIVER METASTASIS, THE TINES WERE FOUND TO BE TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THE ACCOUNT REPORTED THAT THE ELECTRODE WAS TESTED OUTSIDE THE PATIENT AND WORKED WITHOUT ISSUE.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER MTF ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR ZOMETA