BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FREE PSA IMMUNOASSAY

    MDR report key: 6375886 · Received March 3, 2017

    Report

    Report Number
    1823260-2017-00455
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    February 9, 2017
    Report Date
    April 5, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTG
    PMA / PMN Number
    P000027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE INVOLVED SAMPLE COULD NOT BE MADE AVAILABLE FOR FURTHER INVESTIGATIONS. THE CUSTOMER'S OBSERVATION WAS DUPLICATED. A GENERAL PRODUCT PROBLEM COULD BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS TESTED FOR TPSA USING A "CLIA" TEST METHOD AND THE RESULT WAS 0.69 NG/ML. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON AN E601 ANALYZER AND AN E602 ANALYZER. WHEN TESTED ON AN E601 ANALYZER ON (B)(6) 2017, THE SAMPLE HAD A TPSA RESULT OF 0.601 NG/ML AND AN FSA RESULT OF 0.660 NG/ML. THE SAMPLE WAS REPEATED ON THE E601 ANALYZER ON (B)(6) 2017, RESULTING WITH A TPSA VALUE OF 0.600 NG/ML AND A FPSA VALUE OF 0.649 NG/ML. WHEN TESTED ON THE E602 ANALYZER ON (B)(6) 2017, THE SAMPLE HAD A TPSA RESULT OF 0.614 NG/ML AND A FPSA RESULT OF 0.643 NG/ML. THE SAMPLE WAS ALSO TESTED USING AN OUTSOURCED "PSA-ACT"/"ACS-CPSA FREE PSA" TEST METHOD ON THE ADVIA CENTAUR ANALYZER, RESULTING WITH A VALUE OF 0.2 NG/ML. PRELIMINARY INVESTIGATIONS DETERMINED THE ISSUE MAY BE RELATED TO THE VERY LOW PSA CONCENTRATION OF THE SAMPLE. A NON-SPECIFIC REACTION WAS NOT OBSERVED. THE SERIAL NUMBERS OF THE E601 ANALYZER AND E602 ANALYZER USED FOR INVESTIGATIONS WERE ASKED FOR, BUT NOT PROVIDED. THE REAGENT LOT NUMBER USED ON THE INVESTIGATION E601 ANALYZER WAS FPSA REAGENT LOT NUMBER 150990, WITH AN EXPIRATION DATE OF 08/31/2017. THE REAGENT LOT NUMBER USED ON THE INVESTIGATION E602 ANALYZER WAS FPSA REAGENT LOT NUMBER 150990, WITH AN EXPIRATION DATE OF 08/31/2017.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS TOTAL PSA IMMUNOASSAY (TPSA) AND THE ELECSYS FREE PSA IMMUNOASSAY (FPSA) ON A COBAS 6000 E 601 MODULE (E601). THE FPSA VALUE WAS HIGHER THAN THE TPSA VALUE. IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FPSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TPSA ASSAY. THE SAMPLE RESULTED AS 0.66 NG/ML WHEN TESTED FOR TPSA AND RESULTED AS 0.69 NG/ML WHEN TESTED FOR FPSA. THE SAMPLE WAS REPEATED FOR TPSA AND THE RESULT WAS 0.66 NG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE E601 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160872 ELECSYS FREE PSA IMMUNOASSAY TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA MTG ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1