BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOTAL PSA

    MDR report key: 20292597 · Received September 24, 2024

    Report

    Report Number
    1823260-2024-02757
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 25, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    P990056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 E601 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE CALIBRATION AND QC DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE ALARM TRACE; NO ISSUES WERE NOTED. THE INVESTIGATION REVIEWED THE ANALYZER'S DATA. THE SYSTEM REAGENT NOZZLES HAD CRYSTALS; MAINTENANCE WAS NOT PERFORMED REGULARLY. THE PREWASH SYRINGE HAD DIRT AND CONTAMINATION WHICH MIGHT HAVE AFFECTED THE REPORTED ASSAY. THE CUMULATIVE OPERATION LIST SHOWED THAT MEASURING CELL 1 (E-1 MC) WAS USED MORE THAN THE E2-2 MC. A GENERAL REAGENT PROBLEM WAS NOT PRESENT BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA (TPSA) RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 6000 E601 MODULE. THE REPORTER WANTED TO CONFIRM THE INITIAL RESULT AS THEY DID NOT HAVE THE CLINICAL HISTORY YET, PROMPTING THE RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2024: THE INITIAL RESULT OF THE FIRST PATIENT SAMPLE WAS 0.006 NG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 0.182 NG/ML. THE SECOND REPEAT RESULT WAS 0.006 NG/ML WITH A DATA FLAG. ON (B)(6) 2024: THE INITIAL RESULT OF THE SECOND PATIENT SAMPLE WAS 0.006 NG/ML WITH A DATA FLAG. ON (B)(6) 2024: THE FIRST REPEAT RESULT WAS 0.006 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WAS 0.006 NG/ML WITH A DATA FLAG. THE 0.006 NG/ML WITH A DATA FLAG RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175783 ELECSYS TOTAL PSA TOTAL PROSTATE SPECIFIC ANTIGEN MTF ROCHE DIAGNOSTICS 796469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown