BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE® ENTERIC PATHOGENS NUCLEIC ACID TEST

    MDR report key: 16854218 · Received May 2, 2023

    Report

    Report Number
    3006028115-2023-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 2, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    PCH
    UDI-DI
    00840487101568
    PMA / PMN Number
    K140083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEFECTIVE FLOQ SWAB LOT WAS IDENTIFIED VIA CUSTOMER COMPLAINT (B)(4). WITHIN THE COMPLAINT, THE ISSUE WAS IDENTIFIED PRIOR CLINICAL USE AND NO PATIENT RESULTS WERE IMPACTED. ALTHOUGH THERE'S NO HEALTH RISK ASSOCIATED WITH THE COMPLAINT CASE EVENT, THE PRODUCT DEFICIENCY'S POTENTIAL TO IMPACT ASSAY PERFORMANCE WARRANTS AN MDR. PER THE MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE ALIGNING WITH 21 CFR 803.3 AND 803.50, THE MALFUNCTION RESULTS IN THE FAILURE OF THE DEVICE TO PERFORM ITS ESSENTIAL FUNCTION AND COMPROMISES THE DEVICE'S THERAPEUTIC, MONITORING, OR DIAGNOSTIC EFFECTIVENESS, WHICH COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE DEVICE EXPERIENCES REQUIRED BY REGULATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, (B)(6) HOSPITAL NOTIFIED LUMINEX THAT THEY OBSERVED THEIR EP STOOL PREP KIT NOT ABSORBING THE CARY BLAIR BUFFER PROPERLY. THE CUSTOMER WAS UNAWARE OF WHICH SPECIFIC KIT THE SWABS ORIGINATED FROM. LOT OF SWAB PROVIDED: 247P17 - LN:202699 EXP 4/30/2025; EP KIT LOT NOT KNOWN AS STOOL PREP KITS WERE SEPARATED FROM SHIPMENT. NO PATIENT SAMPLES WERE AFFECTED BY THE SWAB CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711933 VERIGENE® ENTERIC PATHOGENS NUCLEIC ACID TEST VERIGENE® EP ASSAY STOOL PREP BUFFER KIT PCH LUMINEX CORPORATION 30-002-023 202699 00840487101568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown