BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12393530 · Received August 31, 2021

    Report

    Report Number
    2023365-2021-00116
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 31, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 WHEN USING THE SIMPLEXA COVID -19 DIRECT ASSAY, BUT RESULTED NEGATIVE UPON REPEAT ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). RUN FILES WERE REQUESTED, BUT THE CUSTOMER HAS NOT RESPONDED TO THIS REQUEST AS OF (B)(6) 2021. IT IS KNOWN THE GENEXPERT TARGETS (E GENE, N2 GENE) ARE DIFFERENT THAN THE SIMPLEXA TARGETS (S GENE, ORF1AB). THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# US10487, 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. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON (B)(6) 2021 WITH 14 NTC REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVE IN EITHER THE S GENE OR ORF1AB TARGETS. NO MALFUNCTIONS OCCURRED DURING RETAIN TESTING. ISSUE UNCONFIRMED. POTENTIAL CAUSES FOR FALSE POSITIVE RESULTS MAY BE AN INSTRUMENT FAILURE OR ERROR, AN OPERATOR ERROR, INCORRECT HANDLING OF REAGENTS DURING TESTING OR STORAGE, OR DEVIATION FROM ASSAY PROCEDURES OUTLINED IN THE PACKAGE INSERT. THE INVESTIGATION CONCLUSION IS PENDING THE RUN FILES AND FURTHER INFORMATION FROM THE CUSTOMER. WITHOUT THE CUSTOMER'S DEVICE OR SUSPECTED FALSE POSITIVE SAMPLES, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 2ND COMPLAINT ON MOL4150 LOT# US10437 FOR SUSPECTED FALSE POSITIVES.

    Description of Event or Problem · 1

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON PATIENT SAMPLES THAT RESULTED POSITIVE WHEN USING THE SIMPLEXA COVID -19 DIRECT ASSAY, BUT RESULTED NEGATIVE UPON REPEAT ON A COMPETITOR ASSAY (CEPHEID GENEXPERT). THE CUSTOMER CONFIRMED THE SUSPECTED FALSE POSITIVE RESULTS WERE NOT REPORTED TO THE DIAGNOSING PHYSICIAN OR CLINICIAN. NO ALLEGED HARM OCCURRED. PATIENT HEALTH INFORMATION AND SAMPLE COLLECTION METHOD WAS NOT PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291446 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 US10437

    Patients

    Seq Age Sex Outcome Treatment
    1