BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSAYED EXTERNAL CONTROL MATERIAL FOR MICROBIOLOGY NUCLEIC ACID AMPLIFICATION

    MDR report key: 16512079 · Received March 9, 2023

    Report

    Report Number
    16512079
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    December 8, 2022
    Report Date
    February 13, 2023
    Manufacturer
    MICROBIOLOGICS INC.
    Product Code
    PMN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING TEST PREPARATION, REAGENT COMPONENT WAS OMITTED. TEST PROCESSED AS NORMAL, AND INSTRUMENT DID NOT FLAG UNACCEPTABLE TEST PREPARATION. A NEGATIVE RESULT WAS REPORTED SINCE ALL QUALITY METRICS WERE MET. BY CHANCE, THIS SAMPLE WAS REPEATED FOR BIANNUAL INSTRUMENT COMPARISON AND A POSITIVE RESULT WAS OBTAINED. A SECOND TECH REPEATED THE TEST ON A FRESH SAMPLE AND VERIFIED THE POSITIVE RESULT. VENDOR NOTIFIED OF FAILURE OF TEST SYSTEM TO NOTIFY OF IMPROPER SAMPLE PREPARATION. PROVIDER NOTIFIED OF ERROR WITHIN 24 HOURS AND THE ERROR DID NOT ALTER THE PATIENT'S TREATMENT COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141049 ASSAYED EXTERNAL CONTROL MATERIAL FOR MICROBIOLOGY NUCLEIC ACID AMPLIFICATION PMN MICROBIOLOGICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA Female