BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSOH HLC-723G8 ANALYZER G8

    MDR report key: 7329823 · Received March 11, 2018

    Report

    Report Number
    8031673-2018-01970
    Event Type
    Malfunction
    Date Received
    March 11, 2018
    Date of Event
    February 23, 2016
    Report Date
    March 11, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    LCP
    PMA / PMN Number
    K071132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. ON 24-FEB-2016, FSE ARRIVED AT THE SITE TO REPLACE THE PEEK TUBING AT THE TUBE LINE FILTER. NO FURTHER ISSUES WERE REPORTED AND NO FURTHER ACTION WAS REQUIRED FROM FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO BROKEN PEEK TUBING FOR THE TUBE LINE FILTER. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-(B)(4).

    Description of Event or Problem · 0

    A CUSTOMER IN THE (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF ACTINOMYCES SPECIES IN ASSOCIATION WITH THE VITEK® MS SYSTEM. VITEK MS OBTAINED THE FOLLOWING RESULTS FOR THREE TESTS: SPOT K2: SINGLE CHOICE TO STREPTOCOCCUS ANGINOSUS; SPOT K3: SINGLE CHOICE TO STREPTOCOCCUS CONSTELLATUS; SPOT K4: SINGLE CHOICE TO ACTINOMYCES MEYERI. TESTING VIA ALTERNATE METHOD (BRUKER) OBTAINED ACTINOMYCES ODONTOLYTICUS. REFERENCE METHOD TESTING (E.G. SEQUENCING) WAS NOT PERFORMED. THE CUSTOMER STATED THAT THE VITEK MS RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN AND HAD NO IMPACT ON PATIENT TREATMENT DECISIONS. THERE HAVE BEEN NO ADVERSE IMPACT ON PATIENT HEALTH. BASED ON REVIEW OF THE MZML LOG FILES AND CALIBRATION LOGS, PRELIMINARY ANALYSIS INDICATES THE CUSTOMER'S SLIDE SPOT PREPARATION IS NON-OPTIMAL AND HETEROGENEOUS; HENCE THE INCONSISTENT ORGANISM IDENTIFICATIONS. IN ADDITION, THE FINE-TUNING OF THE INSTRUMENT DOES NOT MEET ALL SPECIFIED CRITERIA. BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED TO PERFORM VITEK MS INSTRUMENT FINE-TUNING AND PROVIDE ADDITIONAL SPOT PREPARATION TRAINING FOR THE CUSTOMER. THIS WILL BE FOLLOWED BY TESTING OF THE SAME SPECIMEN TO MONITOR FOR CONSISTENCY AND ACCURACY OF RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172872 TOSOH HLC-723G8 ANALYZER G8 G8 LCP TOSOH CORPORATION G8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death