BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE® 2000 PSA

    MDR report key: 16817641 · Received April 26, 2023

    Report

    Report Number
    2432235-2023-00082
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    October 24, 2022
    Report Date
    June 27, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    MTF
    PMA / PMN Number
    REF.H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00082 ON APRIL 26, 2023. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY ELEVATED PSA RESULTS THAT WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT POST PROSTATECTOMY. APRIL 26, 2023 ADDITIONAL INFORMATION: MDR 2432235-2023-00081, MDR 2432235-2023-00082, AND MDR 2432235-2023-00083 WERE FILED FOR THE SAME EVENT. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY ELEVATED PSA RESULTS THAT WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT POST PROSTATECTOMY. SIEMENS IS INVESTIGATING THE ISSUE. IMMULITE 2000 PSA SMN 10380986 IS NOT AVAILABLE IN THE UNITED STATES, HOWEVER, THERE IS A SIMILAR PRODUCT AVAILABLE IN THE UNITED STATES UNDER P930027.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00082 ON APRIL 26, 2023. SIEMENS FILED THE MDR 2432235-2023-00082 SUPPLEMENTAL REPORT 1 ON MAY 19, 2023. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY ELEVATED PSA RESULTS THAT WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT POST PROSTATECTOMY. JUNE 02, 2023 ADDITIONAL INFORMATION: SIEMENS INVESTIGATED. THE CUSTOMER HAD A POST-PROSTATECTOMY PATIENT THAT RECOVERED HIGHER PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS (~0.36 NG/ML) THAN EXPECTED WITH THE IMMULITE 2000 XPI LOT 435 VERSUS THE ALTERNATE METHOD. THE PROSTATECTOMY WAS PERFORMED IN 2020, AND INITIALLY, THE IMMULITE 2000 XPI PSA RESULTS WERE BELOW MEASURING RANGE (< 0.04 NG/ML) AND AS EXPECTED. SINCE (B)(6) OF 2022 THE PSA RESULTS WERE ALWAYS ABOVE THE MEASURING RANGE, THUS A PET-CT WAS PERFORMED, WHICH DID NOT INDICATE ANY PATHOLOGICAL ISSUES. ADDITIONALLY THE SAMPLES WERE TESTED ON THE ALTERNATE METHOD AND RESULTS WERE ALWAYS <0.05 NG/ML. SIEMENS INVESTIGATION INCLUDED AN ASSESSMENT OF REAGENT, INSTRUMENT, AND SAMPLE DATA. REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF THE CUSTOMER'S ADJUSTMENT AND QC WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES. INTERNAL DATA WAS REVIEWED AND LOT 435 RECOVERY WAS ACCEPTABLE AND MET ALL RELEASE CRITERIA. THE PATIENT SAMPLE WAS SENT TO SIEMENS FOR FURTHER INVESTIGATION. THE RETURNED PATIENT SAMPLE WAS TESTED IN REPLICATES OF TWO (2) NEAT AND POST WITH HETEROPHILIC BLOCKING TUBES (HBT) TREATMENT AND TESTED ON AN IMMULITE 2000 WITH PSA KIT LOT D166, ON THE ATELLICA IM ANALYZER WITH PSA LOT 329 AND ON THE DIMENSION VISTA TPSA WITH REAGENT LOT 23044BC. WHEN THE SAMPLE WAS TESTED NEAT ON THE IMMULITE 2000 XPI THE RESULT WAS 0.190 NG/ML, THE ATELLICA IM RESULT WAS <0.00 NG/ML AND THE DIMENSION VISTA RESULT WAS <0.010 NG/ML. POST HBT TREATMENT, THE IMMULITE 2000 XPI PSA RESULT WAS <0.09 NG/ML INDICATING THAT HETEROPHILES ARE CAUSING THE NEAT HIGHER RESULT VERSUS THE OTHER METHODS. PER MMULITE 2000 PSA (PIL2KPS-23, 2020-05-29) IFU: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH THE IMMUNOGLOBULINS INCLUDED IN THE ASSAY COMPONENTS CAUSING INTERFERENCE WITH IN VITRO IMMUNOASSAYS. FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 2432235-2023-00081 SUPPLEMENTAL REPORT 2, MDR 2432235-2023-00082 SUPPLEMENTAL REPORT 2, AND MDR 2432235-2023-00083 SUPPLEMENTAL REPORT 2 WERE FILED FOR THE SAME EVENT. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

    Description of Event or Problem · 0

    FALSELY ELEVATED PSA RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT ON A IMMULITE 2000 XPI INSTRUMENT POST PROSTATECTOMY. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE NON-SIEMENS METHOD. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE PROSTATECTOMY WAS PERFORMED IN 2020. A PET-CT WAS PERFORMED DUE TO THE INCREASE IN VALUES AND WAS WITHOUT PATHOLOGICAL FINDINGS. THE ALTERNATE NON-SIEMENS METHOD RESULTS WERE IN ACCORDANCE WITH PET-CT. THERE ARE NO KNOWN ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PSA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164486 IMMULITE® 2000 PSA PSA IMMUNOASSAY MTF SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED N/A 435

    Patients

    Seq Age Sex Outcome Treatment
    1 Male