BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSANT KPCR MOLECULAR SYSTEM SP

    MDR report key: 11351110 · Received February 19, 2021

    Report

    Report Number
    1219913-2021-00146
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    February 6, 2021
    Report Date
    February 19, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJH
    UDI-DI
    00630414541457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTICED AN INCREASE IN THE INCIDENCE OF LOW-POSITIVE DETERMINATIONS FOR THE FTD SARS-COV-2 ASSAY. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] SAMPLES WHICH HAD PRODUCED LOW-POSITIVE RESULTS IN THIS ASSAY OVER A THREE-DAY PERIOD ((B)(6) 2021) WERE RE-TESTED USING AN ALTERNATE INSTRUMENT SYSTEM. 7 OF THE SAMPLES WHICH HAD PREVIOUSLY TESTED POSITIVE DURING THIS PERIOD WERE FOUND TO BE NEGATIVE UPON RE-TEST. SPECIFIC PATIENT DATA WERE NOT PROVIDED. FOLLOWING THESE OBSERVATIONS OF DISCORDANT POSITIVE RESULTS, THE VERSANT KPCR MOLECULAR SYSTEM SP (SAMPLE PREPARATION INSTRUMENT) WAS SUBJECTED TO A CLEANING/DECONTAMINATION PROCEDURE, AND IMPROVEMENT WAS OBSERVED IN BLANK-SAMPLE TESTING. IT IS CONCLUDED THAT A LIKELY NUCLEIC-ACID CONTAMINATION OCCURRED WITHIN THE VERSANT KPCR MOLECULAR SYSTEM SP INSTRUMENT DURING OPERATOR/ASSAY INTERACTIONS, LEADING TO THE OBSERVED ELEVATION OF RESULTS. NO PRODUCT MALFUNCTION WAS IDENTIFIED. NO FURTHER EVALUATION OF THE PRODUCT IS REQUIRED. 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). MDR WAS FILED FOR RESULTS GENERATED ON (B)(6) 2021; MDR 1219913-2021-00147 WAS FILED FOR RESULTS GENERATED ON (B)(6) 2021 AND MDR 1219913-2021-00148 WAS FILED FOR RESULTS GENERATED ON (B)(6) 2021.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY-ELEVATED RESULTS FOR THE FTD SARS-COV-2 ASSAY AS A RESULT OF CONTAMINATION OF THE VERSANT KPCR MOLECULAR SYSTEM SP. [FAST TRACK DIAGNOSTICS (FTD) IS A SIEMENS HEALTHINEERS COMPANY.] THE SAMPLES IN QUESTION WERE RE-TESTED USING AN ALTERNATE SYSTEM, AND PRODUCED NEGATIVE RESULTS, WHICH WERE REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SARS-COV-2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251451 VERSANT KPCR MOLECULAR SYSTEM SP CLINICAL SAMPLE CONCENTRATOR JJH SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A N/A 00630414541457

    Patients

    Seq Age Sex Outcome Treatment
    1