BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 4404090 · Received January 9, 2015

    Report

    Report Number
    1823260-2015-00176
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 22, 2014
    Report Date
    January 27, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND ANYTHING SUSPICIOUS. HE PERFORMED MAINTENANCE, WHICH INCLUDES AN EXCHANGE OF THE PINCH TUBES AND A PROBE ADJUSTMENT CHECK. NO FURTHER OUTLIERS HAVE BEEN REPORTED TO OCCUR AT THE SITE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE LOW RESULT WAS MOST LIKELY CAUSED BY PRE-ANALYTICAL SAMPLE HANDLING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA). THE PATIENT HAS HAD KNOWN ELEVATED TPSA VALUES. THE SAMPLE INITIALLY RESULTED AS 2.48 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE MEASUREMENT WAS PERFORMED FROM AN ALIQUOT OF THE SAMPLE WHICH WAS PLACED IN A CUP ON TOP OF A TUBE. THE PHYSICIAN DOUBTED THE INITIAL RESULT. THE SAMPLE WAS REPEATED AND RESULTED AS 100.0 NG/ML ON (B)(6) 2014. THE SAMPLE WAS THEN AUTOMATICALLY DILUTED AND REPEATED WITH A DILUTION FACTOR OF 50, RESULTING AS 693.3 NG/ML ON (B)(6) 2014. THE SAMPLE WAS ALSO REPEATED AN ADDITIONAL TIME, RESULTING AS 100.0 NG/ML ON (B)(6) 2014. THE SAMPLE WAS THEN AGAIN AUTOMATICALLY DILUTED AND REPEATED WITH A DILUTION FACTOR OF 50, RESULTING AS 645.6 NG/ML ON (B)(6) 2014. REPEAT MEASUREMENTS PERFORMED ON (B)(6) 2014 WERE PERFORMED AFTER A NEW CALIBRATION WITH A NEW REAGENT LOT (LOT NUMBER 181690). THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TPSA REAGENT LOT NUMBER WAS 178045. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21596 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER LTJ ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR