BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10620795 · Received October 2, 2020

    Report

    Report Number
    1219913-2020-00323
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 11, 2020
    Report Date
    November 12, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NSU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR 1219913-2020-00323 WAS FILED ON 02-OCT-2020. CORRECTION, 23-OCT-2020: THE DATE RECEIVED BY MANUFACTURER (G3) WAS INCORRECTLY NOTED AS 15-SEP-2020 IN THE INITIAL MDR. THE CORRECT DATE IS 14-SEP-2020. MDR 1219913-2020-00297 SUPPLEMENTAL 1 WAS FILED FOR THE RESULTS OBTAINED ON 2020-09-10.

    Additional Manufacturer Narrative · 1

    THE VERSANT KPCR MOLECULAR SYSTEM AD (QUANTSTUDIO 5 DX REAL-TIME PCR) IS AN AUTOMATED AMPLIFICATION AND DETECTION INSTRUMENT FOR NUCLEIC ACIDS USING KPCR (REAL-TIME) TECHNOLOGY WHICH CAN BE USED FOR IN VITRO DIAGNOSTIC ASSAYS. IT IS INTENDED FOR USE BY PROFESSIONALS TRAINED IN LABORATORY TECHNIQUES AND ON THE USE OF THE SYSTEM. THIS DEVICE IS PART OF A USER-CONFIGURABLE, OPEN-PLATFORM SYSTEM WHICH ALLOWS USERS TO PROCESS ASSAYS OF THEIR CHOOSING (INCLUDING USER-DEVELOPED METHODS AND THIRD-PARTY ASSAYS), USING ANALYSIS PARAMETERS WHICH THEY CONTROL. RESULTS CAN VARY DEPENDING ON THE CONFIGURATION SELECTED. THE CUSTOMER'S ASSAY PROTOCOL HAD THE "AMP CHECK STATUS" PARAMETER ENABLED. THIS FEATURE IS INTENDED TO REJECT POTENTIAL FALSE POSITIVE RESULTS, ACCORDING TO CERTAIN AMPLIFICATION CHARACTERISTICS. THE OBSERVED LATE AMPLIFICATION OF THE AFFECTED SAMPLES, WHEN ANALYZED WITH AMP CHECK STATUS ENABLED, LED TO A "TARGET NOT DETECTED" DETERMINATION FOR THESE SAMPLES. IT WAS VERIFIED THAT REANALYSIS OF THE SAME RUN DATA WITH THE AMP CHECK STATUS FEATURE OFF RESULTED IN PROPER DETECTION OF TARGET AMPLIFICATION IN THE IDENTIFIED SAMPLES. THE RUNS AND THE AFFECTED SAMPLES MET VALIDITY REQUIREMENTS. THE CUSTOMER CORRECTLY IDENTIFIED AND REPORTED THE RESULTS AS SARSCOV- 2-POSITIVE, IN ACCORDANCE WITH THE ASSAY'S IFU. THE SOFTWARE FLAGS (TARGET NOT DETECTED) FROM THE VERSANT SYSTEM WERE NOT USED. THE CUSTOMER OBSERVED THE DISCORDANT RESULTS WHILE RUNNING THE FTD SARS-COV-2 ASSAY USING AN UNVALIDATED PROTOCOL. IT WAS DETERMINED THAT THE PROTOCOL USED WAS INCORRECTLY CONFIGURED; CORRECTION OF A PROTOCOL PARAMETER SETTING (DISABLING OF AMP CHECK STATUS) CORRECTS THE ISSUE. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "IT IS THE RESPONSIBILITY OF THE USER'S LABORATORY TO VALIDATE PROCESSES AND PROTOCOLS FOR USE ON THE SYSTEM." THE IFU FOR THE ASSAY (FTD¿ SARS-COV-2, MANUFACTURED BY FAST TRACK DIAGNOSTICS, A SIEMENS HEALTHINEERS COMPANY) 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." THE PRODUCT IS WORKING AS INTENDED. THE OBSERVED ISSUE WAS THE RESULT OF INCORRECT CONFIGURATION OF THE ASSAY PROTOCOL IN THE SYSTEM SOFTWARE BY THE CUSTOMER. MDR 1219913-2020-00297 HAS BEEN FILED FOR THE RESULTS OBTAINED ON (B)(6) 2020.

    Description of Event or Problem · 1

    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) OBSERVED SIX (6) RESULTS WHERE THE SOFTWARE REPORTED "TARGET NOT DETECTED" (NEGATIVE RESULTS), ALTHOUGH AMPLIFICATION (INDICATING PRESENCE OF TARGET) COULD BE SEEN AT ABOUT CYCLE 40, OVER 2 DAYS. THE RUNS AND THE AFFECTED SAMPLES MET VALIDITY REQUIREMENTS. THE CUSTOMER CORRECTLY IDENTIFIED AND REPORTED THE RESULTS AS SARS-COV-2-POSITIVE, IN ACCORDANCE WITH THE ASSAY'S INSTRUCTIONS FOR USE (IFU). THE SOFTWARE FLAGS (TARGET NOT DETECTED) FROM THE VERSANT SYSTEM WERE NOT USED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE "TARGET NOT DETECTED" RESULT FLAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086481 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