BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JQPARROW - MYLA V4.1 DL360 CLI

    MDR report key: 8641696 · Received May 24, 2019

    Report

    Report Number
    9615754-2019-00040
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    OUG
    PMA / PMN Number
    CL 1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMÉRIEUX PERFORMED AN INVESTIGATION IN RESPONSE TO A CUSTOMER COMPLIANT IN WHICH A PATIENT BACT/ALERT® BOTTLE WAS DISCHARGED AT SEVEN (7) 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 SEVEN. 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 BACT/ALERT® FN PLUS BOTTLE THAT WAS NOT INCUBATED FOR THE CORRECT AMOUNT OF TIME ON THE VIRTUO® DUE TO AN INADVERTENT OPERATOR ERROR USING THE MYLA® VERSION 4.1 SOFTWARE (ITEM# 420347, SERIAL# (B)(4)). THE BOTTLE WAS INCUBATED FOR SEVEN (7) DAYS RATHER THAN THE EXPECTED TEN (10) DAYS. THE CUSTOMER INDICATED THAT THE SHORTENED INCUBATION TIME OF THE FN PLUS 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 INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432456 JQPARROW - MYLA V4.1 DL360 CLI ARROW - MYLA V4.1 DL360 CLI OUG BIOMERIEUX, INC. 420347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other