BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14880831 · Received June 30, 2022

    Report

    Report Number
    1650733-2022-00042
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    February 4, 2022
    Report Date
    June 29, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OUT OF AN ABUNDANCE OF CAUTION, A CLASS III RECALL IS WARRANTED FOR SARS EUA LOT AB4042A. RETENTION SAMPLES COULD NOT BE LOCATED FOR TESTING TO CONFIRM PRODUCT PERFORMANCE. THIS RECALL IS REPORTABLE TO FDA AS AN MDR PURSUANT TO THE OBLIGATIONS OF THE EUA (PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020 TO REPORT ANY OCCURRENCE OF FALSE RESULTS). BOTH SARS TARGETS ARE REQUIRED TO BE DETECTED IN ORDER TO MARK THE SAMPLE AS POSITIVE PER INTERNAL QC SPECIFICATIONS. THIS IS DIFFERENT AND MORE STRINGENT FROM CLINICAL USE WHERE ONLY 1 TARGET IS REQUIRED FOR A POSITIVE CALL. INTERNAL QC TESTING DETECTED ONE POSITIVE TARGET IN HOUSE. IF THE ORF1AB TARGET IS NOT DETECTED IN A POSITIVE SAMPLE, THE N TARGET STILL MAKES A POSITIVE CALL. BECAUSE OF THIS, WHILE IT IS POSSIBLE TO GET A FALSE NEGATIVE RESULT WITH BOTH TARGETS MISSING, IT IS HIGHLY UNLIKELY.

    Description of Event or Problem · 0

    IN THE ARIES SARS-COV-2 ASSAY, THE QC CONTROL USED DURING INTERNAL RELEASE TESTING CONTAINS BOTH ORF1AB AND N TARGETS. BOTH ARE REQUIRED TO BE DETECTED IN ORDER TO MARK THE SAMPLE AS POSITIVE PER INTERNAL QC SPECIFICATIONS. THIS IS DIFFERENT FROM CLINICAL USE WHERE ONLY 1 TARGET IS REQUIRED FOR A POSITIVE CALL. IF ONLY 1 TARGET IS DETECTED DURING INTERNAL QC LOT RELEASE TESTING, THE LOT SHOULD BE RECORDED AS FAILING BECAUSE BOTH TARGETS WERE NOT DETECTED. FOR THE AFFECTED LOTS, THE TEST SAMPLES FOR POSITIVITY WERE INADVERTENTLY MARKED AS 'INVALID' RATHER THAN 'FAIL' AND RELEASED TO THE FIELD RATHER THAN BEING IDENTIFIED AS NONCONFORMING. REFERENCE ESCALATION CASE (B)(4) FOR FURTHER INVESTIGATION. THE CAPA REVIEW TEAM DECIDED A CAPA IS WARRANTED FOR THIS DOCUMENTATION ISSUE, REFERENCE CAPA (B)(4). THE CONTROL MATERIAL USED IN THE ORIGINAL QC TESTING FOR THESE LOTS (PN: 10408) WAS DETERMINED TO HAVE EXPERIENCED DEGRADATION IN CONCENTRATION OF THE ORF1AB TARGET OVER TIME. THIS IS AN INTERNAL PART USED FOR QC LOT RELEASE TESTING AND IS NOT SOLD TO CUSTOMERS. THE INVESTIGATION SUMMARY FOR THE POSITIVE CONTROL IS ATTACHED TO RA-LMNX-22-0071 AS ATTACHMENT 1. LUMINEX R&D FORMULATED NEW LOTS OF THE QC POSITIVE CONTROL MATERIAL WITH ANALYSIS SHOWING THE CONCENTRATION OF BOTH TARGETS IS IN THE EXPECTED RANGE OF 100X LOD CONCENTRATION. ARIES QC USED THIS NEW MATERIAL IN SUBSEQUENT RETENTION TESTING FOR 10 AFFECTED LOTS: AB4719A, AB4882A, AB5081A, AB5120A, AB5140A, AB5282A, AB4659A, AB4800A, AB5082A, AND AB5147A. ALL VALID RESULTS RETURNED POSITIVE CALLS ON BOTH TARGETS AS REQUIRED PER THE QC SPECIFICATION. SARS EUA LOT AB4042A DID NOT UNDERGO ADDITIONAL TESTING AS RETENTION MATERIAL WAS UNABLE TO BE LOCATED. ADDITIONAL RETENTION SAMPLE TESTING WAS NEEDED TO CONFIRM PRODUCT PERFORMANCE WITH THE NEW POSITIVE CONTROL MATERIAL AS THE DHR SHOWS QC FAILURE AND MATERIAL WAS RELEASED TO THE FIELD. HOWEVER, BECAUSE THE RETENTIONS COULD NOT BE LOCATED FOR TESTING, WE CANNOT CONFIRM PRODUCT PERFORMANCE AND A RECALL IS WARRANTED FOR SARS EUA LOT AB4042A. THE CAPA REVIEW TEAM DECIDED A CAPA IS WARRANTED FOR THIS MISSING RETENTION ISSUE, THE CAPA # IS TBD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394805 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB4042A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown