BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT

    MDR report key: 4674217 · Received April 9, 2015

    Report

    Report Number
    1950204-2015-00004
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 19, 2015
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    JSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR GRAM-POSITIVE RODS WERE SUBMITTED FOR EVALUATION BECAUSE THE VITEK 2 ANC CARDS MISIDENTIFIED THE ORGANISMS WHEN COMPARED TO RESULTS OBTAINED BY A REFERENCE LAB (MAYO CLINIC). ISOLATE (B)(4) WAS IDENTIFIED BY ANC CARDS AS A. NAESLUNDII, WITH A 86% ACCEPTABLE ID, WHEREAS MAYO CLINIC IDENTIFIED IT AS L. RHAMNOSUS / L. CASEI. FOR ISOLATE (B)(4), A LOW DISCRIMINATION CALL OF A. NAESLUNDII / L. ACIDOPHILUS WAS OBTAINED, BUT THE MAYO CLINIC IDENTIFIED THE ORGANISM AS L. RHAMNOSUS / L. CASEI. FOR ISOLATE (B)(4), AN ACCEPTABLE ID (87%) OF A. NAESLUNDII WAS OBTAINED, BUT MAYO CLINIC IDENTIFIED THE ORGANISM AS L. JENSENII. FOR ISOLATE (B)(4), A VERY GOOD ID (95%) OF A. MEYERI WAS OBTAINED ON CARDS, BUT THE MAYO CLINIC IDENTIFIED IT AS A. ODONTOLYTICUS. INVESTIGATION: THE FOUR ISOLATES WERE SUB-CULTURED TO COLUMBIA AGAR AND GROWN UNDER ANAEROBIC CONDITIONS AT 37 DEGREES CELSIUS FOR FOUR DAYS. TESTING WAS PERFORMED IN DUPLICATE ON THE SAME LOT OF ANC CARDS AS THAT USED BY THE CUSTOMER, ALONG WITH TWO RANDOM LOTS. THE 16S SEQUENCING AND VITEK MS TESTING WERE ALSO PERFORMED. IT WAS DETERMINED ISOLATE (B)(4) WAS NOT VIABLE, SO TESTING COULD NOT BE PERFORMED ON THIS ORGANISM. (B)(4): ON ONE OF THE ANC CARDS FROM THE CUSTOMER LOT, AN ACCEPTABLE ID (88%) OF A. VAGINAE WAS OBTAINED; FOR THE SECOND CARD, A GOOD ID (89%) OF L. PARACASEI WAS OBTAINED. BOTH RANDOM CARD LOTS GAVE AN IDENTIFICATION OF L. PARACASEI (89% AND 90%). THE 16S SEQUENCING IDENTIFIED THE ORGANISM AS L. RHAMNOSUS, WITH A 99% IDENTITY MATCH, AS DID THE VITEK MS, WHICH ALSO GAVE A 99.1% IDENTITY MATCH TO L. RHAMNOSUS. (B)(4): ON BOTH OF THE ANC CARDS FROM THE CUSTOMER LOT, A LOW DISCRIMINATION CALL OF L. CASEI / L. PARACASEI WAS OBTAINED. ON BOTH OF THE RANDOM CARD LOTS, AN EXCELLENT ID (96%) OF L. CASEI WAS OBTAINED. THE 6S SEQUENCING IDENTIFIED THE ORGANISM AS L. RHAMNOSUS, WITH A 99% IDENTITY MATCH. VITEK MS WAS UNABLE TO IDENTIFY THE ORGANISM. (B)(4): BOTH ANC CARDS FROM THE CUSTOMER LOT GAVE LOW DISCRIMINATION CALLS OF L. ACIDOPHILUS/ L. GASSERI. ON ONE OF THE RANDOM LOTS, A GOOD ID (89%) OF A.ODONTOLYTICUS WAS OBTAINED, AND ON THE OTHER RANDOM LOT, A LOW DISCRIMINATION CALL OF C. HISTOLYTICUM / L. HILGARDII / A. ODONTOLYTICUS WAS OBTAINED. THE 16S SEQUENCING IDENTIFIED THE ORGANISM AS L. JENSENII, WITH A 99% IDENTITY MATCH. VITEK MS ALSO IDENTIFIED THE ORGANISM AS L. JENSENII, WITH A 96.5% IDENTITY MATCH. ISOLATE (B)(4) WAS NOT VIABLE, SO TESTING COULD NOT BE PERFORMED ON THIS ORGANISM. NONE OF THE THREE ISOLATES TESTED HAVE ORGANISM IDENTIFICATIONS THAT ARE CLAIMED IN THE VITEK 2 6.01 ANC DATABASE. AS INDICATED IN THE INSTRUCTIONS FOR USE, TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION. THE INVESTIGATION RESULTS INDICATE THE ANC TEST KIT IS PERFORMING WITHIN DOCUMENTED PERFORMANCE CLAIMS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT AN ORGANISM MISIDENTIFICATION USING THE VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION (ANC ID) CARD (REF (B)(4), LOT 244336210, EXPIRATION 27FEB16). A VITEK® 2 ANC RESULT OF ACTINOMYCES NAESLUNDII WAS REPORTED TO THE CLINICIAN AND THE PATIENT WAS PRESCRIBED PENICILLIN, CIPROFLOXACIN AND FLAGYL. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL. THE PATIENT ISOLATE WAS SENT TO A REFERENCE LAB FOR CONFIRMATION OF THE VITEK® 2 ANC RESULT, AND IDENTIFIED AS LACTOBACILLUS RHAMNOSUS (METHOD OF TESTING IS UNKNOWN). AS LACTOBACILLUS RHAMNOSUS IS NOT A CLAIMED ORGANISM FOR THE VITEK® 2 ANC ID TEST KIT, THIS ORGANISM IS NOT PRESENT IN THE ANC DATABASE AND CANNOT BE REPORTED IN CONJUNCTION WITH THE ANC TEST KIT. AS INDICATED IN THE VITEK® 2 ANC ID TEST KIT PACKAGE INSERT, "TESTING OF UNCLAIMED SPECIES MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION". THE PENICILLIN AND CIPROFLOXACIN PRESCRIBED TO THE PATIENT ARE ALSO INDICATED FOR TREATMENT OF LACTOBACILLUS SPECIES. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE DEMOGRAPHICS OR CLINICAL STATUS OF THE PATIENT. THERE IS NO INDICATION FROM THE HOSPITAL OR TREATING PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL'S HAVE BEEN REQUESTED FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235285 VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT VITEK® 2 ANC ID CARD JSP BIOMÉRIEUX, INC. 244336210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention