BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT ®

    MDR report key: 16458416 · Received March 1, 2023

    Report

    Report Number
    9615754-2023-00008
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: A CUSTOMER IN UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING A POTENTIAL MISIDENTIFICATION WHEN TESTING A SENTINEL ORGANISM USING THE VITEK MS SYSTEM - REFERENCE 410895 (SERIAL NUMBER# (B)(6)). VITEK MS RESULT: DETAILS ARE UNKNOWN (NO ANY DATA PROVIDED); EXPECTED IDENTIFICATIONS : UNKNOWN; OTHER METHOD : UNKNOWN; CULTURE CONDITIONS: UNKNOWN; ISSUE DATE: UNKNOWN; FINE TUNING DATE BEFORE THE ISSUE: UNKNOWN. INVESTIGATION RESULTS: LOCAL CUSTOMER SERVICE HAS TRIED MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR HAVING ADDITIONAL DATA BUT HE DID NOT REPLIED. COMPLAINT ANALYSIS INFORMATION PROVIDED ARE NOT SUFFICIENT TO IDENTIFY SIMILAR COMPLAINTS. AS IT WAS NOT POSSIBLE TO INVESTIGATE THIS CASE AND TO FIND THE CAUSE OF THIS ISSUE, THE COMPLAINT ANALYSIS COULD NOT HAVE BEEN PERFORMED. CONCLUSION : THE INFORMATION PROVIDED ARE NOT SUFFICIENT TO IDENTIFY THE POTENTIAL ROOT CAUSE OF THE ISSUE REPORTED. LOCAL CUSTOMER SERVICE HAS TRIED MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR HAVING ADDITIONAL DATA BUT HE DID NOT REPLIED. IT IS NOT POSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Description of Event or Problem · 0

    THE VITEK® MS SYSTEMS A MASS SPECTROMETER USING MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION-TIME OF FLIGHT) TECHNOLOGY FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM CLINICAL SPECIMENS. A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF OBTAINING A POTENTIAL MISIDENTIFICATION WHEN TESTING A SENTINEL ORGANISM USING THE VITEK MS SYSTEM - REFERENCE (B)(4). AT THE TIME OF THE ASSESSMENT, NO ADDITIONAL DETAILS HAVE BEEN PROVIDED REGARDING THE EXPECTED IDENTIFICATION OF THE STRAIN AND THE POTENTIAL WRONG IDENTIFICATION RESULT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. THIS EVENT HAS BEEN REVIEWED FOR VIGILANCE REPORTING IN ACCORDANCE WITH 21 CFR 803, CONCERNING MEDICAL DEVICE REPORTING. BIOMÉRIEUX INTERNAL STANDARD OPERATIONAL PROCEDURES STATES THAT ERRONEOUS TEST RESULTS COULD RESULT IN A LACK OF APPROPRIATE DIAGNOSIS OR THERAPY, CONTINUED ADMINISTRATION OF INAPPROPRIATE ANTIMICROBIALS, OR OTHER POTENTIALLY TOXIC THERAPIES. THIS REVIEW HAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA FOR REPORTING AS A MALFUNCTION. ALTHOUGH THIS EVENT DOES NOT ALLEGE THAT DEATH OR SERIOUS INJURY ACTUALLY OCCURRED, IT HAS BEEN DETERMINED THAT THERE IS POTENTIAL FOR SERIOUS INJURY SHOULD THE SITUATION RECUR WHILE TESTING A PATIENT ISOLATE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196660 VITEK MS INSTRUMENT ® VITEK MS INSTRUMENT ® - QBN BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown