BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 11474617 · Received March 12, 2021

    Report

    Report Number
    1219913-2021-00189
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 18, 2021
    Report Date
    May 7, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    QJR
    UDI-DI
    05400829005906
    PMA / PMN Number
    EUA200571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2021-00189 WAS FILED IN ASSOCIATION WITH THE FTD SARS-COV-2 ASSAY ON 12-MAR-2021 TO REPORT A FALSE-POSITIVE RESULT. CORRECTION, 05-MAY-2021: THE DATE OF SIEMENS' INITIAL AWARENESS OF THE ISSUE WAS 22-FEB-2021, RATHER THAN 24-FEB-2021, AS INDICATED IN THE INITIAL REPORT. CONCLUSIONS STATED IN THE INITIAL REPORT ARE STILL APPLICABLE; NO FURTHER EVALUATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL POSITIVE RESULT WHICH WAS IDENTIFIED AS DISCORDANT WAS AN ERRONEOUS INTERPRETATION DUE TO USE ERROR. IN THE RUN OF (B)(6) 2021, THE AFFECTED SAMPLE HAD PRODUCED AN IRREGULAR AMPLIFICATION CURVE WHICH HAD BEEN MISINTERPRETED AS POSITIVE DUE TO INAPPROPRIATE ANALYSIS PARAMETERS AND LACK OF MANUAL ADJUSTMENT OF BASELINE AND THRESHOLD. UPON SUBSEQUENT REANALYSIS OF THE SAME RUN USING THE APPROPRIATE METHODS, THE SAMPLE IN QUESTION WAS DETERMINED AS NEGATIVE. THE INSTRUCTIONS FOR USE FOR THE FTD SARS-COV-2 ASSAY STATE THAT "...IT IS RECOMMENDED TO CHECK ALL AMPLIFICATION TRACES TO DETERMINE IF A MANUAL ADJUSTMENT OF THE THRESHOLD AND BASELINES IS REQUIRED." THE OBSERVED RESULT MISINTERPRETATION WAS THE RESULT OF USE ERROR WHEN ANALYZING ASSAY RESULTS. NO PRODUCT MALFUNCTION WAS IDENTIFIED. NO FURTHER EVALUATION OF THE PRODUCT IS REQUIRED. A FALSE POSITIVE RESULT WOULD HAVE NEGLIGIBLE CLINICAL IMPACT AS MANAGEMENT AND TREATMENT DECISIONS ARE BASED ON SEVERITY OF CLINICAL PRESENTATION AND MANAGEMENT PRIMARILY CONSISTS OF SUPPORTIVE CARE. ALTHOUGH THERE IS NO POTENTIAL FOR SERIOUS INJURY IN THIS CASE, AN MDR WILL BE REPORTED TO THE FDA AS A REQUIREMENT OF THE EMERGENCY USE AUTHORIZATION (EUA).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A POSITIVE FTD SARS-COV-2 RESULT WHICH WAS FOUND TO BE DISCORDANT RELATIVE TO RE-TEST AND SUBSEQUENT REANALYSIS. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE PATIENT WAS TESTED AS A SCREENING TEST UPON ENTRANCE TO THE HOSPITAL. BASED ON THE POSITIVE TEST RESULT, THE PATIENT WAS MOVED TO AN AREA WITH OTHER POSITIVE PATIENTS. AFTER THE NEGATIVE RETEST THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND REMAINED ISOLATED AT HOME FOR 14 DAYS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FTD SARS-COV-2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372124 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A SC20-96-51 05400829005906

    Patients

    Seq Age Sex Outcome Treatment
    1