BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSANT KPCR MOLECULAR SYSTEM AD (QUANTSTUDIO 5 DX REAL- TIME PCR)

    MDR report key: 11733682 · Received April 27, 2021

    Report

    Report Number
    1219913-2021-00234
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    February 18, 2021
    Report Date
    May 7, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NSU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL POSITIVE FTD SARS-COV-2 RESULT WAS OBTAINED AS A CONSEQUENCE OF A USE ERROR, WHEREIN THE CUSTOMER DID NOT FOLLOW RECOMMENDATIONS REGARDING RESULT ANALYSIS PROVIDED IN THE ASSAY'S INSTRUCTIONS FOR USE (IFU). THE ERRONEOUS POSITIVE RESULT WAS NOT INITIALLY IDENTIFIED AS INCORRECT, AND WAS REPORTED TO THE PHYSICIAN THE FOLLOWING MORNING. THE ERROR WAS IDENTIFIED WHEN THE AFFECTED SAMPLE WAS RANDOMLY SELECTED TO BE INCLUDED IN A VERIFICATION RUN FOLLOWING ON-SITE SERVICE ACTIVITY, AND WAS REPEAT-TESTED USING THE SAME METHOD. THE REPEAT-TEST RESULT (USING THE SAME METHOD AND PLATFORM) WAS NEGATIVE FOR SARS-COV-2. ADDITIONAL TESTING USING THE SAME ASSAY IN CONJUNCTION WITH A CEPHEID PLATFORM WAS USED TO CONFIRM THE NEGATIVE RESULT. THE FOLLOWING WERE NOTED: - THE BASELINE IS NOT CORRECTLY ADJUSTED. - THE CT VALUES OBTAINED (8.747 FOR SARS-COV-2, 4.499 FOR THE IC) ARE INHERENTLY SUSPECT, AS THEY ARE IMPLAUSIBLY LOW (INDICATING EXCEPTIONALLY HIGH VIRAL CONCENTRATION), AND EFFECTIVELY CLINICALLY IMPOSSIBLE. - THE SARS-COV-2 AMPLIFICATION CURVE WHICH WAS ERRONEOUSLY IDENTIFIED AS POSITIVE DOES NOT DISPLAY THE REQUISITE EXPONENTIAL CURVE SHAPE. THE IFU FOR THE FTD¿ SARS-COV-2 ASSAY STATES THE FOLLOWING: "IF CRITERIA LISTED IN THE CRITERIA FOR A VALID RUN SECTION ARE MET, ANY PATIENT SAMPLE DISPLAYING AN EXPONENTIAL TRACE SHALL BE CONSIDERED AS POSITIVE FOR ONE OF THE PATHOGENS TARGETED BY THE KIT." FOLLOWING THE IDENTIFICATION OF THE ERRONEOUS POSITIVE RESULT, THE CAUSE WAS CONFIRMED TO BE USE ERROR ASSOCIATED WITH RESULT ANALYSIS. THE CUSTOMER WAS ADVISED, AND NO RESIDUAL ISSUES WERE IDENTIFIED. THE PRODUCT IS WORKING AS INTENDED.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2021-00234 WAS SUBMITTED IN ASSOCIATION WITH THE VERSANT® KPCR MOLECULAR SYSTEM AD ON 27-APR-2021 TO REPORT A FALSE-POSITIVE RESULT FROM THE FTD¿ SARS-COV-2 ASSAY. UPDATED INFORMATION, 05-MAY-2021: CORRECTION: THE DATE OF THE EVENT WAS (B)(6) 2021, RATHER THAN (B)(6) 2021, AS INITIALLY REPORTED. HAS BEEN UPDATED TO INCLUDE THE CORRECT DATE. THIS REPORT HAS BEEN DETERMINED TO REPRESENT A DUPLICATE SUBMISSION: MDR 1219913-2021-00189, FILED IN ASSOCIATION WITH THE FTD SARS-COV-2 ASSAY ON (B)(6) 2021, DOCUMENTS THE SAME EVENT. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    A CUSTOMER USING THE VERSANT® KPCR MOLECULAR SYSTEM AD WITH MIPLX SOFTWARE TO RUN THE FTD¿ SARS-COV-2 ASSAY (MANUFACTURED BY FAST TRACK DIAGNOSTICS, A SIEMENS HEALTHINEERS COMPANY) PRODUCED A POSITIVE RESULT FOR ONE PATIENT WHICH WAS LATER FOUND TO BE NEGATIVE BY REPEAT TESTING. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR OF CHANGES IN TREATMENT RESULTING FROM THE DISCORDANT POSITIVE RESULT. THE AFFECTED PATIENT HAD BEEN PREVIOUSLY COVID-POSITIVE, AND THEREFORE DID NOT REQUIRE OR RECEIVE TREATMENT. WHEN SCREENED AGAIN WITHIN 48 HOURS, THE PATIENT WAS FOUND TO BE SARS-COV-2-NEGATIVE, AND DISCHARGED. THE PATIENT UNDERWENT A PERIOD OF QUARANTINE DUE TO CONTACT WITH OTHER POSITIVE PATIENTS AT THE HOSPITAL, BUT SUBSEQUENT TESTING SHOWED CONTINUED PCR-NEGATIVE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627894 VERSANT KPCR MOLECULAR SYSTEM AD (QUANTSTUDIO 5 DX REAL- TIME PCR) INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS NSU SIEMENS HEALTHCARE DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1