BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 13283250 · Received January 18, 2022

    Report

    Report Number
    2023365-2022-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 19, 2021
    Report Date
    January 18, 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 THREE (3) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS FROM (B)(6) 2021 ARE AS FOLLOWS: SAMPLE ID(B)(6) : @0733 = NEGATIVE, @0922 = S GENE (33.2) ORF1AB (32.2) ,SAMPLE ID (B)(6) : @0733 = NEGATIVE, @0922 = S GENE (31.2) ORF1AB (32.1) ,AND SAMPLE ID (B)(6) : @0733 = NEGATIVE, @0922 = ORF1AB (33.2). FOR THE RUN @0733 AN NTC WAS RUN ON WELL 2 AND WAS DETECTED FOR BOTH TARGETS AND FAILED. THIS WOULD BE CONSIDERED AN INVALID RUN AND BE REPEATED. FOLLOWING THE REPEAT TEST @0922, THE DETECTION OF THE 3 SAMPLES AT OR ABOVE 32 CTS MEANS THOSE SAMPLES WERE LIKELY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. IT IS NOT KNOWN WHAT THE CORRECT INTERPRETATION SHOULD BE AS THE DETAILS OF THE SAMPLES AND PATIENTS DIAGNOSES WERE NOT PROVIDED. THE CUSTOMER'S DEVICE AND SUSPECTED FALSE POSTIIVE SAMPELS WERE NOT PROVIDED FOR INVESTIGATION. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# US13346, 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 12/22/21 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 1ST COMPLAINT ON MOL4150 LOT# US13328 FOR SUSPECTED FALSE POSITIVES.

    Additional Manufacturer Narrative · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON THREE (3) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS FROM (B)(6) 2021 ARE AS FOLLOWS: SAMPLE ID(B)(6) : @0733 = NEGATIVE, @0922 = S GENE (33.2) ORF1AB (32.2) ,SAMPLE ID (B)(6) : @0733 = NEGATIVE, @0922 = S GENE (31.2) ORF1AB (32.1) ,AND SAMPLE ID (B)(6) : @0733 = NEGATIVE, @0922 = ORF1AB (33.2). FOR THE RUN @0733 AN NTC WAS RUN ON WELL 2 AND WAS DETECTED FOR BOTH TARGETS AND FAILED. THIS WOULD BE CONSIDERED AN INVALID RUN AND BE REPEATED. FOLLOWING THE REPEAT TEST @0922, THE DETECTION OF THE 3 SAMPLES AT OR ABOVE 32 CTS MEANS THOSE SAMPLES WERE LIKELY NEAR THE LIMIT OF DETECTION OF THE SIMPLEXA ASSAY. IT IS NOT KNOWN WHAT THE CORRECT INTERPRETATION SHOULD BE AS THE DETAILS OF THE SAMPLES AND PATIENTS DIAGNOSES WERE NOT PROVIDED. 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# US13346, 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 1ST COMPLAINT ON MOL4150 LOT# US13328 FOR SUSPECTED FALSE POSITIVES.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON THREE (3) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE SAMPLES INITIALLY TESTED NEGATIVE BUT THEN POSITIVE ON THE SAME 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.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON THREE (3) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE SAMPLES INITIALLY TESTED NEGATIVE BUT THEN POSITIVE ON THE SAME 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
    2233706 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 US13328

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown