BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE ASCENCIODX COVID-19 TEST AND THE ASCENCIODX MOLECULAR DETECTOR

    MDR report key: 18608323 · Received January 30, 2024

    Report

    Report Number
    3026000572-2024-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    November 17, 2023
    Report Date
    January 29, 2024
    Manufacturer
    ADL DIAGNOSTICS, INC, D/B/A ANAVASI DIAGNOSTICS
    Product Code
    QJR
    PMA / PMN Number
    NONENONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROBLEM DESCRIPTION: THE ASCENCIODX MOLECULAR DETECTOR USES REAL-TIME FLUORESCENCE TO DETECT THE PRESENCE OF THE TARGET IN A CLINICAL SAMPLE. THE LIGHT INTENSITY USED BY THE DEVICE IS READ BY A SENSOR FOR WHICH THERE MAY BE AN ARTIFICIALLY LOW "MAXIMUM INTENSITY" THRESHOLD IN THE DEVICE SETTINGS. AS A RESULT, UNDER CERTAIN CONDITIONS, THE UNDULY CONSTRAINED SETTINGS MAY CAUSE THE DEVICE TO STOP PROCESSING AND YIELD A MALFUNCTION MESSAGE INSTEAD OF A POSITIVE, NEGATIVE, OR INCONCLUSIVE RESULT. HAZARD: THE MALFUNCTION MESSAGE IS OBSERVED TO OCCUR WITHIN THE FIRST FIVE (5) MINUTES OR SO OF THE SAMPLE PROCESSING. AS A RESULT, THE HAZARD ASSOCIATED WITH THIS MALFUNCTION IS A DELAY OF TEST RESULT. INVESTIGATION CONCLUSION: THE DEVICE SETTINGS WERE REVISED TO INCREASE THE MAXIMUM INTENSITY THRESHOLD TO ALLOW A WIDER RANGE OF VARIATION OF PRODUCTION COMPONENTS THAT ARE WITHIN DEFINED SPECIFICATIONS. MANUFACTURER ACTION: ALL DEVICES IN THE FIELD WERE IMMEDIATELY REPLACED WITH DEVICES WITH REVISED SETTINGS AT NO COST TO CUSTOMER. AN RMA WAS ISSUED TO CUSTOMERS TO FACILITATE RETURN OF AFFECTED DEVICES UPON RECEIPT OF REPLACEMENT DEVICES.

    Description of Event or Problem · 0

    LABORATORY CUSTOMER, AN ORGANIZATION RUNNING CLINICAL STUDIES, RECEIVED A MALFUNCTION MESSAGE DURING A POSITIVE CONTROL TEST ON THE ASCENCIODX MOLECULAR DETECTOR (DEVICE). DURING A POSITIVE CONTROL TEST ON DEVICE, (B)(6), THE DEVICE DISPLAYED A "MALFUNCTION, TEST FAILED" MESSAGE. CUSTOMER REPORTED THAT UPON SUBSEQUENT SCANNING OF THE QR CODE (DISPLAYED AT COMPLETION OF TEST OR FOLLOWING A MALFUNCTION), LED TO A WEB PAGE MESSAGE THAT INDICATED A SPECIFIC MALFUNCTION CODE (CODE=10). THE CUSTOMER FOLLOWED DISPLAYED INSTRUCTIONS TO DISCONTINUE USE OF DEVICE AND TO CONTACT ANAVASI DIAGNOSTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031533 THE ASCENCIODX COVID-19 TEST AND THE ASCENCIODX MOLECULAR DETECTOR ASCENCIODX MOLECULAR DETECTOR QJR ADL DIAGNOSTICS, INC, D/B/A ANAVASI DIAGNOSTICS 1000-00ENUS 2418700304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown