BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 13389432 · Received January 28, 2022

    Report

    Report Number
    2023365-2022-00004
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 3, 2022
    Report Date
    January 28, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. ACCORDING TO THE CUSTOMER, AN INCREASE IN POSITIVITY RATE WAS OBSERVED PRIOR TO THE NTC FAILING. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: ON (B)(6) 2022@1124: NTC FAILED FOR DETECTION OF ORF1AB (33.5), ON (B)(6) 2022@1312: SAMPLE 10599: ORF1AB (32.0); ON (B)(6) 2022@1449: SAMPLE 10561: S GENE (31.2) ORF1AB (32.8), SAMPLE 10565: S GENE (32.8) ORF1AB (32.4) , SAMPLE 10556: S GENE (34.9) , SAMPLE 10562: ORF1AB (31.9); ON (B)(6) 2022@1617: SAMPLE 10575: S GENE (33.1) ORF1AB (32.7), SAMPLE 10620: S GENE (32.4) ORF1AB (32.2), SAMPLE 10619: S GENE (31.1) ORF1AB (32.0), SAMPLE 10578: S GENE (31.8) ORF1AB (34.4) , AND SAMPLE 10581: S GENE (34.6); ON (B)(6) 2022@1742: SAMPLE 10583: S GENE (33.5), SAMPLE 10580: S GENE (33.0) ORF1AB (31.4); ON (B)(6) 2022@1535: NTC FAILED FOR DETECTION OF S GENE (34.3); ON (B)(6) 2022@0640: SAMPLE 10581: ORF1AB (34.7), SAMPLE 10644: S GENE (32.4) ORF1AB (32.3); ON (B)(6) 2022@0916: NTC FAILED FOR DETECTION OF S GENE (31.1) ORF1AB (30.3); ON (B)(6) 2022@1122: 2 NTC FAILED FOR DETECTION OF S GENE (32.3, 31.1) ORF1AB (33.8, 33.0). BASED ON THE SAMPLES ABOVE BEING DETECTED AT OR ABOVE 32 CTS WITH SOME HAVING ONLY 1 TARGET DETECTED, IT IS LIKELY THESE ARE SAMPLES NEAR THE LIMIT OF DETECTION FO THE SIMPLEXA ASSAY AND COULD REPEAT AS NEGATIVE ON THE SAME ASSAY OR EVEN COMPETITOR ASSAYS. IT WAS OBSERVED THAT NTC (NO TEMPLATE CONTROLS) WERE FAILING DUE TO DETECTION OF ONE OR BOTH COVID TARGETS. THIS ACTS AS THE NEGATIVE CONTROL AND DETECTION OF COVID TARGETS INDICATES SOME LEVEL OF CONTAMINATION PRESENT. DOM: 12/16/21. EXP: 12/22. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# US13740, 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) 2022 WITH 14 NTC REPLICATES WITH ZERO 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 1ST COMPLAINT ON MOL4150 LOT# US13543 FOR SUSPECTED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN UNKNOWN NUMBER OF PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. ACCORDING TO THE CUSTOMER, AN INCREASE IN POSITIVITY RATE WAS OBSERVED PRIOR TO THE NTC FAILING. 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
    2360728 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 US13543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown