BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCER ANTIGEN 125

    MDR report key: 3384118 · Received October 3, 2013

    Report

    Report Number
    1823260-2013-06060
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTK
    PMA / PMN Number
    K980240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS REPORTED IN THE INITIAL MEDWATCH WERE PROVIDED VERBALLY. THE CUSTOMER THEN PROVIDED HARDCOPY DATA WITH SLIGHTLY DIFFERENT VALUES THAT WERE CONFIRMED TO BE CORRECT. THE INITIAL CA 125 WAS ACTUALLY 67.72 U/ML, RATHER THAN 63 U/ML. THE ARCHITECT RESULT OF 39 U/ML WAS CORRECT; THIS TEST WAS PERFORMED ON (B(6) 2013. THE RESULT OF 26 U/ML FROM THE CENTAUR WAS ACTUALLY 23 U/ML; THIS TEST WAS PERFORMED ON (B)(6) 2013. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. BASED ON THE FACT THAT RESULTS FROM MULTIPLE DRAWS YIELDED SIMILAR RESULTS WITH THE ROCHE METHOD AND AN EXAMINATION OF THE CALIBRATION AND QUALITY CONTROL DATA, AN ISSUE WITH THE LOCAL TEST SYSTEM COULD BE EXCLUDED. DIFFERENCES IN RESULTS BETWEEN DIFFERENT CA-MARKER METHODS ARE WELL KNOWN.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE RESULT FOR CA 125 II: CANCER ANTIGEN 125, ON ONE PATIENT SAMPLE. THE INITIAL CA 125 WAS 63 U/ML. THE PATIENT WAS SENT BY HER DOCTOR TO ANOTHER LABORATORY TO CONFIRM THE RESULT. THAT LABORATORY REPORTED A NORMAL RESULT; THE METHOD USED AND ACTUAL RESULT WERE NOT KNOWN. THE CUSTOMER SENT THE INITIAL SAMPLE TO TWO OTHER LABORATORIES. ONE LABORATORY USED AN ARCHITECT ANALYZER AND OBTAINED A RESULT OF 39 U/ML WITH "NV <37 U/ML." THE SECOND LABORATORY USED A CENTAUR ANALYZER TO OBTAIN A RESULT OF 26 U/ML WITH "NV <35 U/ML." ALTHOUGH THE PATIENT RECEIVED AN MR SCAN, THE PATIENT WAS NOT HARMED BY ANY ACTIONS TAKEN. THE LOT NUMBER OF THE CA 125 REAGENT WAS 171867. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499218 CANCER ANTIGEN 125 TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) LTK ROCHE DIAGNOSTICS NA 171867

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR MOTILEX (CLEBOPRIDE MALATE ACID)| DEURSIL (URSODEOXYCHOLIC ACID)