BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM POSITIVE TEST KIT

    MDR report key: 6934991 · Received October 10, 2017

    Report

    Report Number
    1950204-2017-00329
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 20, 2017
    Report Date
    January 12, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LQL
    UDI-DI
    03573026131920
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) HAD NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION RESULT WHEN TESTING ON TWO DIFFERENT LOTS OF VITEK® 2 GP ID CARDS (2420352403 AND 24203301133). VITEK 2 IDENTIFIED THE STRAIN AS STREPTOCOCCUS GALLOLYTICUS SSP PASTERUIANUS. THE STRAIN WAS CONFIRMED AS STREPTOCOCCUS PASTEURI VIA 16S RDNA SEQUENCING METHOD. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER DID NOT SUBMIT THE STRAIN FOR FURTHER EVALUATION. THIS ORGANISM, STREPTOCOCCUS PASTEURI, IS NOT CLAIMED FOR THE VITEK 2 GP ID TEST KIT. AFTER RESEARCH BY THE R&D STRAIN COLLECTION DEPARTMENT, IT WAS DETERMINED THAT THE SPECIES STREPTOCOCCUS PASTEURI IS NOT RECOGNIZED BY THE TAXONOMY VALIDATION COMMITTEE, SO IT IS ABSENT IN LPSN, DSMZ. IN THE NCBI TAXONOMY, THE SPECIES IS LISTED BUT WITH THE COMMENT "UNPUBLISHED NAME", ONLY THE SPECIES S.PASTEURIANUS IS CITED. ACCORDING TO THESE ELEMENTS, IT IS CONSIDERED THAT THERE WAS NO MISIDENTIFICATION ON THE VITEK 2 GP ID CARD. THE VITEK 2 GP ID CARDS PERFORMS AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF A STREPTOCOCCUS PASTEURI PATIENT ISOLATE IN ASSOCIATION WITH VITEK® 2 GP ID TEST KIT (REF 21342, LOT 2420352403). PER THE CUSTOMER, THIS PATIENT WAS VERY ILL WHEN HOSPITALIZED. ENDOCARDITIS WAS SUSPECTED; THEREFORE, A BLOOD CULTURE WAS DONE. ON (B)(6) 2017, VITEK® 2 IDENTIFIED THE ISOLATE FROM THIS PATIENT'S BLOOD CULTURE AS STREPTOCOCCUS GALLOLYTICUS SSP PASTEURIANUS. ON (B)(6) 2017, THE STRAIN WAS SENT OUT TO BE CONFIRMED VIA SEQUENCING METHOD (16S RDNA SEQUENCING). THE STRAIN WAS CONFIRMED AS STREPTOCOCCUS PASTEURI. ON (B)(6) 2017, THE PATIENT EXPIRED DUE TO GASTROINTESTINAL BLEEDING. THE CUSTOMER STATED THAT THERE WAS NO INCORRECT TREATMENT. THE PATIENT WAS TREATED FOR ENDOCARDITIS AND RECEIVED THE USUAL TREATMENT GIVEN FOR STREPTOCOCCI. THE TREATMENT WAS NOT DEPENDENT ON THE SPECIES. THE CUSTOMER STATED THAT THERE WAS NO DELAY IN TREATMENT OR HARM TO THE PATIENT DUE TO THIS DISCREPANT RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715649 VITEK® 2 GRAM POSITIVE TEST KIT VITEK® 2 GP TEST KIT LQL BIOMERIEUX INC. 2420352403 03573026131920

    Patients

    Seq Age Sex Outcome Treatment
    1