BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES HSV 1&2 ASSAY

    MDR report key: 12753939 · Received November 4, 2021

    Report

    Report Number
    1650733-2021-00020
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 4, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    PGI
    UDI-DI
    00840487100295
    PMA / PMN Number
    K161495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL ASSOCIATED CUSTOMER-PROVIDED DOCUMENTATION AND INTERNALLY GENERATED INVESTIGATION NOTES AGAINST THE CRITERIA SET FORTH IN DOCUMENT (B)(4) (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE), THIS COMPLAINT DOES MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE ARIES HSV 1&2 ASSAYS ARE SOLD OR DISTRIBUTED. BASED ON THE 12/2/21 EMAIL FROM (B)(4), THIS FOLLOW-UP 001 REPORT IS BEING SUBMITTED TO CHANGE IT FROM A 5 DAY REPORT TO A 30 DAY REPORT.

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL ASSOCIATED CUSTOMER-PROVIDED DOCUMENTATION AND INTERNALLY GENERATED INVESTIGATION NOTES AGAINST THE CRITERIA SET FORTH IN DOCUMENT (B)(4) (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE), THIS COMPLAINT DOES MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE ARIES HSV 1&2 ASSAYS ARE SOLD OR DISTRIBUTED. IMPLEMENTING GUIDANCE RECEIVED FROM A RECENT FDA INSPECTION, THE ASSOCIATED RECALL INVESTIGATION WAS REASSESSED ON (B)(6) 2021 AND THE EVENT FOUND TO BE POTENTIALLY REPORTABLE AS A 5 DAY MDR. THIS MDR REPORT IS SUBMITTED WITHIN 5 DAYS OF 11/4/2021.

    Description of Event or Problem · 0

    ON SEPTEMBER 27, 2021 FIELD QUALITY ASSURANCE NOTIFIED REGULATORY AFFAIRS OF THE CUSTOMER (B)(6) OBSERVING LEAKS WHILE USING ARIES HSV 1&2 ASSAY - IVD (PART NUMBER 50-10017, LOTS AB3600A AND AB3560A) FOLLOWING SAMPLE RUNS. THE CUSTOMER REPORTED RESIDUE BUILDUP ON THE ACTUATION BLOCK AND VALVE KEYS OF THEIR ARIES SYSTEMS. ARIES ASSAY CASSETTES ARE DESIGNED TO BE A SEALED AND CONTAINED PRODUCT. WITHIN THE CASSETTE, SAMPLE PREPARATION AND WASHING UTILIZES A SERIES OF REAGENTS TO LYSE AND PURIFY HUMAN DNA FOR PCR ANALYSIS. CASSETTES THAT LEAK WHILE BEING UTILIZED HAVE THE POTENTIAL TO LEAK THE INTERNAL REAGENTS AND PATIENT SAMPLE INTO THE ARIES SYSTEM AND THE ARIES MAGAZINE THAT LOADS INTO THE INSTRUMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2021 FIELD QUALITY ASSURANCE NOTIFIED REGULATORY AFFAIRS OF THE CUSTOMER MAYO FOUNDATION OBSERVING LEAKS WHILE USING ARIES HSV 1&2 ASSAY - IVD (PART NUMBER 50-10017, LOTS AB3600A AND AB3560A) FOLLOWING SAMPLE RUNS. THE CUSTOMER REPORTED RESIDUE BUILDUP ON THE ACTUATION BLOCK AND VALVE KEYS OF THEIR ARIES SYSTEMS. ARIES ASSAY CASSETTES ARE DESIGNED TO BE A SEALED AND CONTAINED PRODUCT. WITHIN THE CASSETTE, SAMPLE PREPARATION AND WASHING UTILIZES A SERIES OF REAGENTS TO LYSE AND PURIFY HUMAN DNA FOR PCR ANALYSIS. CASSETTES THAT LEAK WHILE BEING UTILIZED HAVE THE POTENTIAL TO LEAK THE INTERNAL REAGENTS AND PATIENT SAMPLE INTO THE ARIES SYSTEM AND THE ARIES MAGAZINE THAT LOADS INTO THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648280 ARIES HSV 1&2 ASSAY ARIES HSV 1&2 ASSAY PGI LUMINEX CORPORATION 50-10017 AB3600A AND AB3560A 00840487100295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown