BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 12789267 · Received November 10, 2021

    Report

    Report Number
    2023365-2021-00148
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 10, 2021
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES AND ENVIRONMENTAL WIPE TESTS WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. SIMPLEXA RESULTS OF 15 RUN FILES FROM (B)(6) 2021 WERE REVIEWED AND THE MOST NOTABLE ITEMS WERE OBSERVED: - SAMPLE ID (B)(4) TESTED TWICE ON (B)(6) 2021 WITH DETECTION FOR BOTH TARGETS RANGING FROM 14.3 - 19.5. - (B)(6) 2021: POSITIVE CONTROL NOT DETECTED. - 10/8/21, SAMPLE ID (B)(4): INTERNAL CONTROL NOT DETECTED. - (B)(6) 2021, SAMPLE ID (B)(4): S GENE (32.6), ORF1AB (38.0), SAMPLE ID (B)(4): S GENE (33.3) - (B)(6) 2021: SAMPLE ID (B)(4): S GENE (33.6), SAMPLE ID (B)(4): S GENE (31.5), ORF (31.4), SAMPLE ID X1002432: S GENE (32.9). - (B)(6) 2021: SEVERAL INSTRUMENT PARTS AND LAB WORKSPACE SWABS WERE DETECTED FOR BOTH TARGETS WITH CT RANGES = 6.8 - 23.4 (INDICATING ENVIRONMENTAL CONTAMINATION). THE CUSTOMER DID NOT COMMUNICATE WHICH SAMPLES WERE SUSPECTED FALSE POSITIVES. BASED ON ALL OF THE RUN INFORMATION, IT IS LIKELY THE POSITIVE PATIENT SAMPLES WERE DETECTED NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. ENVIRONMENTAL TESTING OF THE INSTRUMENT AND LAB WORKSPACE CONFIRMED A LEVEL OF CONTAMINATION AND IS LIKELY CONTRIBUTING TO THE TO THE FALSE POSITIVES, BUT THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSITIVE SAMPLES WERE NOT PROVIDED FOR INVESTIGATION. TROUBLESHOOTING THE CONTAMINATION AT THE CUSTOMER SITE IS STILL ONGOING. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151, LOT# US12515, 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. 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# US12487 FOR SUSPECTED FALSE POSITIVES.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES AND ENVIRONMENTAL WIPE TESTS WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED NO PATIENT RESULTS WERE REPORTED TO A 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
    1682892 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 US12487

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown