BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11798125 · Received May 10, 2021

    Report

    Report Number
    2023365-2021-00005
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 7, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS WITH A PATIENT SAMPLE TESTING POSITIVE ON THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON THE COMPETITOR ASSAY (CEPHEID GENEXPERT). THE CUSTOMER HAS NOT RETURNED ANY ISSUE KITS FOR INVESTIGATION NOR HAVE THEY PROVIDED ANY PATIENT SAMPLES FOR TESTING. DATA FROM THE COMPETITOR ASSAY (CEPHEID) WAS NOT PROVIDED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 10162N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. A TOTAL OF 35 NO-TEMPLATE CONTROL (NTC) REPLICATES WERE RUN AND RESULTED IN ZERO (0) OCCURRENCES OF FALSE POSITIVES IN EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAIN TESTING WAS COMPLETED ON 4/22/21 WITH RETAINS OF THE REACTION MIX MOL4151 LOT# 10162N USING 8 REPLICATES OF A NON-TEMPLATE CONTROL (NTC). ALL NTC REPLICATES WERE VALID FOR THE INTERNAL CONTROL AND RESULTED IN NO FALSE DETECTION IN BOTH THE S GENE AND ORF1AB TARGETS. NO INTERNAL CONTROL FAILURES WERE OBSERVED, THEREFORE ALL RESULTS WERE VALID. NO MALFUNCTIONS OCCURRED DURING RETAIN TESTING AND THE ISSUE IS CONSIDERED UNCONFIRMED. THIS IS THE FIRST COMPLAINT ON MOL4150 LOT# 9767N FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 1

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS, PER THE CONDITIONS OF AUTHORIZATION FOR THIS PRODUCT, SUSPECTED FALSE NEGATIVES AND FALSE POSITIVES WILL BE REPORTED UNDER 21 CFR 803, AS WELL AS SIGNIFICANT CHANGES IN EXPECTED PERFORMANCE CHARACTERISTICS. THERE HAS BEEN NO REPORT OF PATIENT INJURY/DEATH DUE TO CONTRIBUTION OF ALLEGED FALSE TESTING RESULTS IN THIS EVENT OR OTHERS WITH THIS IVD; HOWEVER, THIS IS BEING REPORTED CONSERVATIVELY IN THE CASE THAT IF THIS ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR A PATIENT TO INCUR A SERIOUS INJURY/DEATH. DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS WITH A PATIENT SAMPLE TESTING POSITIVE ON THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE ON THE COMPETITOR ASSAY (CEPHEID GENEXPERT). THE FALSE RESULT WAS NOT REPORTED TO A PHYSICIAN OR PATIENT. THE CUSTOMER CONFIRMED PATIENT TREATMENT WAS NOT IMPACTED BY THE FALSE RESULT AND NO ALLEGED HARM OCCURRED. PATIENT INFORMATION AND PATIENT SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699572 SIMPLEXA COVID-19 DIRECT ASSAY REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA QJR DIASORIN MOLECULAR LLC 9767N

    Patients

    Seq Age Sex Outcome Treatment
    1