BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT

    MDR report key: 7955551 · Received October 11, 2018

    Report

    Report Number
    1950204-2018-00423
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER REPORTED A MISIDENTIFICATION OF KLEBSIELLA PNEUMONIAE SSP. PNEUMONIAE AS KLEBSIELLA OXYTOCA WHEN TESTED WITH THE VITEK® 2 GN ID CARD LOT# 2410534203 AND USING VITEK 2 SOFTWARE VERSION 8.01. THE CUSTOMER REPORTED THE ANTIBIOGRAM MATCHED K. OXYTOCA, BUT TESTING OF A BLOOD CULTURE ISOLATE AND RE-TEST OF URINE ISOLATE FROM THE SAME PATIENT RESULTED IN AN IDENTIFICATION OF K. PNEUMONIAE SSP. PNEUMONIAE. NO OTHER REFERENCE TESTING WAS PERFORMED. THE CUSTOMER STRAIN AND RAW DATA ARE NOT AVAILABLE. THE ONLY SET UP INFORMATION PROVIDED BY THE CUSTOMER WAS THAT THE TESTING FOR THE URINE ISOLATE WAS FROM CPSE AGAR AND FROM DRIGALSKI FOR THE BLOOD CULTURE ISOLATE. NO TESTING WAS PERFORMED TO CONFIRM THE IDENTIFICATION OF K. PNEUMONIAE SSP. PNEUMONIAE. TWO GN LAB REPORTS WERE SUBMITTED. ONE SHOWED A VERY GOOD IDENTIFICATION OF K. PNEUMONIAE SSP PNEUMONIAE. THE OTHER SHOWED AN EXCELLENT IDENTIFICATION OF K. OXYTOCA WITH TWO ATYPICAL POSITIVE REACTIONS (LARL, 5KG) FOR AN IDENTIFICATION OF K. PNEUMONIAE SSP. PNEUMONIAE ACCORDING TO THE GN KNOWLEDGE BASE. ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS OR AN ATYPICAL STRAIN. HOWEVER, WITHOUT THE STRAIN OR RAW DATA, IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. THE VITEK 2 GN LOT # 2410534203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A MISIDENTIFICATION OF A URINE SAMPLE KLEBSIELLA PNEUMONIAE AS KLEBSIELLA OXYTOCA IN ASSOCIATION WITH THE VITEK® 2 GRAM-NEGATIVE (GN) IDENTIFICATION ID) TEST KIT. A BLOOD CULTURE RESULT FROM THE SAME PATIENT PROVIDED THE KLEBSIELLA PNEUMONIAE RESULT. RETEST OF THE URINE SAMPLE OBTAINED AN ORGANISM IDENTIFICATION TO KLEBSIELLA PNEUMONIAE AS WELL. THE CUSTOMER STATED THAT PATIENT TREATMENT (ROCEPHIN) WAS BASED ON THE BLOOD CULTURE RESULT. THE INITIAL RESULT OF K. OXYTOCA FROM THE URINE SAMPLE WAS NOT USED IN THE PATIENT THERAPY DECISIONS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796092 VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX INC. 2410534203 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1