BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUO® A UNIT

    MDR report key: 8696145 · Received June 13, 2019

    Report

    Report Number
    1950204-2019-00180
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    UDI-DI
    03573026369767
    PMA / PMN Number
    K161816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX PERFORMED AN INVESTIGATION IN RESPONSE TO A CUSTOMER COMPLIANT IN WHICH A PATIENT BACT/ALERT® BOTTLE WAS DISCHARGED AT FIVE (5) DAYS INSTEAD OF TEN (10) DAYS. THE CUSTOMER CHANGED THE MAXIMUM TEST TIME AT THE LIS TO TEN DAYS BUT THE BOTTLE WAS DISCARDED INTO THE WASTE BIN AT DAY FIVE. THE ISSUE WAS CONFIRMED BY REVIEWING THE SYSTEM LOGS FILES; HOWEVER, BIOMÉRIEUX COULD NOT DUPLICATE THE ANOMALY DURING INVESTIGATIONAL TESTING AT BIOMÉRIEUX. A FIRMWARE CODE REVIEW DETERMINED THE ROOT CAUSE OF THE INCORRECT BOTTLE DISCHARGE TIME WAS DUE TO A VIRTUO® SOFTWARE/ FIRMWARE TIMING ANOMALY. ONCE THE BOTTLE DATA IS SCANNED AND IDENTIFIED BY THE INSTRUMENT, MYLA® IMMEDIATELY DOWNLOADS THE BOTTLE MESSAGE THAT CONTAINS THE MAXIMUM TEST TIME (MTT) CHANGE. THE MAXIMUM TEST TIME IS TRANSMITTED TO THE VIRTUO® PC IMMEDIATELY UPON IDENTIFICATION OF THE BOTTLE BARCODE AT THE VIRTUO INSTRUMENT. THERE ARE MULTIPLE MESSAGES SENT TO THE MASTER CONTROL BOARD (MCB), ABOUT THE SAME BOTTLE, WHICH CONTAIN THE SAME BOTTLE ID, IN A TIME FRAME OF APPROXIMATELY 1 SECOND. DURING THIS INFLUX OF INFORMATION TO THE MCB, THERE IS POTENTIAL FOR THE SYSTEM TO MISINTERPRET THE MTT CHANGE.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A BACT/ALERT® BOTTLE THAT WAS NOT INCUBATED FOR THE CORRECT AMOUNT OF TIME ON THE VIRTUO® A UNIT (ITEM# 411660, SERIAL# (B)(4)). THE BOTTLE WAS INCUBATED FOR FIVE (5) DAYS RATHER THAN THE EXPECTED TEN (10) DAYS. THE CUSTOMER INDICATED THAT THE SHORTENED INCUBATION TIME OF THE BOTTLE CAUSED THE TREATING PHYSICIAN TO POSTPONE A VASCULAR TISSUE GRAFT PROCEDURE FOR THE PATIENT. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS PROVIDED NO FURTHER DETAILS RELATED TO THE PATIENT CONDITION OR IF THE VASCULAR TISSUE GRAFT HAS BEEN COMPLETED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488691 VIRTUO® A UNIT VIRTUO® A UNIT MDB BIOMERIEUX, INC. 411660 03573026369767

    Patients

    Seq Age Sex Outcome Treatment
    1 Other