BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)

    MDR report key: 3162659 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03521
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2012
    Report Date
    October 26, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    P990056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS OF THE INVOLVED SAMPLE HAVE DETERMINED THAT THERE IS INDICATION OF AN UNKNOWN INTERFERENT IN THE SAMPLE. THIS IS INDICATED BY A NON-LINEAR BEHAVIOR IN THE TPSA ASSAY. THE FPSA ASSAY DOES NOT SEEM TO BE AFFECTED BY THE INTERFERING SUBSTANCE IN THE SAMPLE AS THE FPSA ASSAY RESULTS WERE LINEAR DURING DILUTION. (B)(4) INTERFERENCE COULD BE EXCLUDED. UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONTACT FROM THE CUSTOMER WAS RECEIVED ON (B)(4) 2015 AND THE CUSTOMER REPORTED THAT THEY HAD A NEW SAMPLE FROM THE SAME PATIENT AVAILABLE FOR INVESTIGATION. THIS SAME PATIENT WAS NOTED TO HAVE AN AGE OF 65 TO 70 YEARS. THE PATIENT HAS NO OBSERVATIONS OF A MALIGNANT TUMOR. THE CUSTOMER PROVIDED RESULTS FROM THE E MODULE ANALYZER OF 3.12 NG/ML FOR TPSA AND 4.47 NG/ML FOR FPSA. IT WAS ASKED, BUT IT IS NOT KNOWN WHEN THE CUSTOMER PROVIDED RESULTS WERE MEASURED. IT WAS ALSO ASKED, BUT IT IS NOT KNOWN IF THE CUSTOMER PROVIDED RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PROVIDED FOR INVESTIGATION AND TESTED ON E411 MODULE SERIAL NUMBER (B)(4) ON (B)(6) 2015, RESULTING AS 3.03 NG/ML FOR TPSA AND 4.74 NG/ML FOR FPSA. DURING INVESTIGATIONS, THE SAMPLE WAS ALSO TESTED ON A BECKMAN ACCESS ANALYZER USING THE ACCESS HYBRITECH PSA AND ACCESS HYBRITECH FREE PSA METHODS. THE RESULTS FROM THE BECKMAN ACCESS ANALYZER WERE 5.45 NG/ML FOR TPSA AND 3.54 NG/ML FOR FPSA. IT WAS STATED THAT THE RESULTS FROM THE INVESTIGATION WILL BE REPORTED BACK TO THE CUSTOMER. THE CUSTOMER'S RESULTS WERE REPRODUCED IN THE INVESTIGATION, BUT WERE DIFFERENT FROM THE BECKMAN ACCESS RESULTS. IT WAS ASKED, BUT IT IS NOT KNOWN IF THIS PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE TPSA AND FPSA REAGENT LOT NUMBERS AND EXPIRATION DATES USED AT THE CUSTOMER SITE WERE ASKED FOR, BUT NOT PROVIDED. THE TPSA REAGENT LOT NUMBER USED ON THE E411 ANALYZER DURING INVESTIGATIONS WAS LOT 181675, WITH AN EXPIRATION DATE OF 01/31/2016. THE FPSA REAGENT LOT NUMBER USED ON THE E411 ANALYZER DURING INVESTIGATIONS WAS LOT 183535, WITH AN EXPIRATION DATE OF 05/31/2016.

    Additional Manufacturer Narrative · 1

    A PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE REPRODUCIBLE. FURTHER TESTING OF THE PATIENT'S SAMPLE INDICATED THE PRESENCE OF AN INTERFERING SUBSTANCE, SUCH AS AN ANTI-IDIOTYPE OR AUTO-ANTIBODY. THE EXACT NATURE OF THE INTERFERING SUBSTANCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) AND FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) RESULTS FOR ONE PATIENT ON THEIR E-MODULE. THE PATIENT'S INITIAL TPSA RESULT WAS 3.66 NG/ML. THE PATIENT'S INITIAL FPSA RESULT WAS 5.73 NG/ML. THE PATIENT'S SAMPLE WAS ALSO TESTED WITH A TANDEM METHOD, ADDITIONAL DETAILS NOT PROVIDED. THE TPSA RESULT WAS 7.88 NG/ML. THE FPSA RESULT WAS 2.96 NG/ML. ON (B)(6) 2012, THE PATIENT'S TPSA RESULT FROM THE E-MODULE WAS 4.37 NG/ML. THE FPSA RESULT FROM THE E-MODULE WAS 6.57 NG/ML. ON (B)(6) 2013, THE PATIENT'S SAMPLE WAS TESTED WITH A TANDEM METHOD, ADDITIONAL DETAILS NOT PROVIDED. THE TPSA RESULT WAS 8.88 NG/ML. THE FPSA RESULT WAS 3.86 NG/ML. ON (B)(6) 2013, THE PATIENT'S TPSA RESULT WAS 4.21 NG/ML. THE FPSA RESULT WAS 5.26 NG/ML. IT WAS UNKNOWN IF ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE TPSA AND FPSA REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262698 TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS MTF ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR