BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY

    MDR report key: 14569758 · Received June 1, 2022

    Report

    Report Number
    2023365-2022-00025
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 3, 2022
    Report Date
    June 1, 2022
    Manufacturer
    DIASORIN MOLECULAR LLC
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 TWO (2) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT DID NOT MATCH THE CLINICAL SYMPTOMS OF THE PATIENTS. RUN ANALYSIS OF THE SIMPLEXA RESULTS ARE AS FOLLOWS: (B)(6) 2022: SAMPLE ID (B)(6): FLU A (NEG), FLU B (31.6), COVID (25.6). (B)(6) 2022: SAMPLE ID (B)(6) : FLU A (NEG), FLU B (27.7), COVID (31.9). ACCORDING TO THE CUSTOMER, THE 2 SAMPLES ARE DIFFERENT PATIENT SAMPLES AND THE RESULTS DID NOT MATCH THE CLINICAL SYMPTOMS OF THE PATIENTS. THE CUSTOMER DID NOT STATE IF THE SAMPLES WERE RUN ON ANOTHER PLATFORM TO CONFIRM IF THE RESULTS WERE SUPPOSED TO BE NEGATIVE. BASED ON THE INFORMATION GIVEN, IT APPEARS THESE ARE VALID POSITIVE RESULTS FOR FLU B AND COVID. THE CUSTOMER HAS YET TO RESPOND TO THE RESPONSE GIVEN BY TECHNICAL SERVICES. DOM: (B)(6) 2021, EXP: 12/2022. BATCH RECORD REVIEW SHOWED THE CRITICAL COMPONENT, REACTION MIX MOL4251 LOT# 14649N 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 3 TARGETS. NO MALFUNCTIONS OCCURRED DURING QC RELEASE TESTING. RETAINS OF THE SUSPECTED DEVICE WERE TESTED ON 5/20/22 WITH 14 NTC REPLICATES WITH ZERO (0) OCCURRENCES OF FALSE POSITIVE IN ANY OF THE 3 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. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE AT THIS TIME. THIS IS THE 1ST COMPLAINT FOR FALSE POSITIVE ON MOL4250 LOT# 14648N.

    Description of Event or Problem · 0

    DIASORIN MOLECULAR LLC RECEIVED A COMPLAINT ALLEGING FALSE POSITIVE RESULTS ON TWO (2) PATIENT SAMPLES WITH THE SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY, BUT DID NOT MATCH THE CLINICAL SYMPTOMS OF THE PATIENTS. THE CUSTOMER CONFIRMED NO ALLEGED HARM OCCURRED. SAMPLE COLLECTION METHOD WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265683 SIMPLEXA COVID-19 & FLU A/B DIRECT ASSAY REAL TIME RT-PCR ASSAY FOR THE IVD QUALITATIVE DETECTION OF SARS-COV-2 VIRAL RNA QJR DIASORIN MOLECULAR LLC 14648N

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown