BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 11913833 · Received June 1, 2021

    Report

    Report Number
    2023365-2021-00060
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    August 24, 2020
    Report Date
    June 1, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON PATIENT SAMPLES THAT RESULTED POSITIVE (S GENE ONLY) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE WHEN REPEATED ON THE SAME SIMPLEXA ASSAY LOT. RUNS FROM THIS KIT LOT WERE NOT PROVIDED BY THE CUSTOMER, BUT THEY HAVE HAD SIMILAR COMPLAINTS OF ONLY S GENE POSITIVES THAT REPEATED AS NEGATIVE ON OTHER LOTS. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. NO PATIENT DATA OR INFORMATION WAS PROVIDED. RETAINS OF MOL4151, LOT# 8002N WERE TESTED ON 8/31/2020 WITH EIGHT (8) NO TEMPLATE CONTROLS (NTC) REPLICATES AND ZERO (0) FALSE POSITIVES OCCURRED IN EITHER S GENE OR ORF1AB TARGETS. THE ALLEGED FALSE POSITIVES COULD NOT BE REPLICATED WITH THE NTC TESTING THAT MIMICKED NEGATIVE SAMPLE TESTING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# 8002N, MET ALL QC RELEASE CRITERIA PRIOR TO KIT RELEASE. MOL4151, LOT# 8002N WAS TESTED USING A TOTAL OF 35 NO-TEMPLATE CONTROLS (NTC) REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVES IN EITHER S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. THIS IS THE 1ST COMPLAINT ON MOL4150, LOT# 7925N 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 ON PATIENT SAMPLES THAT RESULTED POSITIVE (S GENE ONLY) WHEN USING THE SIMPLEXA COVID-19 DIRECT ASSAY, BUT NEGATIVE WHEN REPEATED ON THE SAME SIMPLEXA ASSAY LOT. THE CUSTOMER CONFIRMED THE ALLEGED FALSE POSITIVE RESULTS WERE NOT REPORTED TO A DIAGNOSING PHYSICIAN AND NO ALLEGED HARM OCCURRED. PATIENT INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813994 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 8001N

    Patients

    Seq Age Sex Outcome Treatment
    1