BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 DIRECT ASSAY

    MDR report key: 18980551 · Received March 26, 2024

    Report

    Report Number
    2023365-2024-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 26, 2024
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    UDI-DI
    2081619027044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 NTC/NEGATIVE CONTROL WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: RUN ON (B)(6) 2024: SAMPLE 206 - IC FAILURE. RUN ON (B)(6) 2024 @1326: SAMPLE 216 - IC FAILURE. RUN ON (B)(6) 2024 @1458: SAMPLES 216/2, 220 - IC FAILURE. RUN ON (B)(6) 2024 @1255: SAMPLES 227, 230 - IC FAILURE. RUN ON (B)(6) 2024 @1450: SAMPLES 233, 227 - IC FAILURE. INTERNAL CONTROL FAILURES WERE SPORADIC AND DID NOT OCCUR ON ALL SAMPLES. DSM SUGGESTED TO THE CUSTOMER TO DECONTAMINATE THEIR LAB AND USE FRESH VIALS OF NTC/TRANSPORT MEDIA TO DETERMINE IF CONTAMINATION WAS AN ISSUE. CUSTOMER PERFORMED THE DECONTAMINATION BUT WAS STILL SEEING INVALID ERRORS DURING THEIR QC TESTING. A MAS VISITED THE CUSTOMER SITE TO ASSIST WITH DECONTAMINATION AND NO FURTHER ISSUES OCCURRED. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4151 LOT# 17740N 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 ANY OF THE TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON (B)(6)2024 WITH 14 NTC REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVE IN ANY OF THE TARGETS. NO MALFUNCTIONS OCCURRED DURING RETAIN TESTING. 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 ASSAY ISSUE IS UNCONFIRMED AND MOST LIKELY DUE TO CONTAMINATION AT THE CUSTOMER SITE. MAS ASSISTANCE WITH DECONTAMINATION RESOLVED THE ISSUE. NO FURTHER ACTIONS ARE REQUIRED. THIS IS THE 1ST COMPLAINT FOR FALSE POSITIVES ON MOL4150 LOT 17736N.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON AN NTC/NEGATIVE CONTROL WITH THE SIMPLEXA COVID-19 DIRECT ASSAY. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435793 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 17736N 2081619027044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown