BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 6536892 · Received May 2, 2017

    Report

    Report Number
    1950204-2017-00139
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF GEMELLA MORBILLORUM AS GEMELLA SANGUINIS IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THREE (3) GRAM POSITIVE ORGANISMS WERE SUBMITTED FOR VITEK 2 EVALUATION BECAUSE THE GP CARD MISIDENTIFIED THE ORGANISMS AS GEMELLA SANGUINIS. THE ORGANISMS WERE SUBBED AND TESTING INCLUDED BOTH THE CUSTOMER LOT AND A RANDOM LOT OF GP CARDS. API® 20 STREP, VITEK® MS, AND 16S SEQUENCING WERE ALSO PERFORMED. ISOLATE 911425: THE CUSTOMER GP CARD LOT GAVE A VERY GOOD ID (93%) OF G. SANGUINIS, WHEREAS THE RANDOM LOT GAVE A LOW DISCRIMINATION CALL OF G. HAEMOLYSANS/G. SANGUINIS. API 20 STREP GAVE AN EXCELLENT ID TO GENUS: G. HAEMOLYSANS/G. MORBILLORUM. VITEK MS GAVE A LOW DISCRIMINATION, WITH A 50% IDENTITY G. MORBILLORUM AND 50% IDENTITY G. HAEMOLYSANS. 16S SEQUENCING IDENTIFIED THE ORGANISM AS G. MORBILLORUM, WITH A 97% IDENTITY MATCH. THEREFORE, THE FINAL IDENTIFICATION IS G. MORBILLORUM. A COMPARISON OF CARD REACTION RESULTS FOR G. SANGUINIS AGAINST EXPECTED REACTION RESULTS FOR G. MORBILLORUM GAVE ONE (1) ATYPICAL NEGATIVE REACTION (APPA) AND FIVE (5) ATYPICAL POSITIVE REACTIONS (PHOS, DSOR, BACI, DMAN, DRAF), WHICH LED TO THE MISIDENTIFICATION. A COMPARISON OF CARD REACTION RESULTS FOR THE LOW DISCRIMINATION CALL AGAINST EXPECTED REACTION RESULTS FOR G. MORBILLORUM GAVE ONE (1) ATYPICAL NEGATIVE REACTION (APPA) AND TWO (2) ATYPICAL POSITIVE REACTIONS (PHOS, BACI) THAT LED TO THE MISIDENTIFICATION. ISOLATE 911426: BOTH GP CARDS GAVE AND EXCELLENT ID (99%) OF G. SANGUINIS. API 20 STREP GAVE AN EXCELLENT ID TO GENUS: G. HAEMOLYSANS/G. MORBILLORUM. BOTH VITEK MS AND 16S SEQUENCING IDENTIFIED THE ORGANISM AS G. SANGUINIS (BOTH WITH 99% IDENTITY MATCHES). THEREFORE, THE FINAL IDENTIFICATION IS G. SANGUINIS, AND CARDS ARE PERFORMING AS EXPECTED FOR THIS ORGANISM. ISOLATE 911427: ON THE CUSTOMER CARD LOT, A LOW DISCRIMINATION CALL OF G. HAEMOLYSANS/G. SANGUINIS WAS OBTAINED. ON THE RANDOM LOT, A VERY GOOD ID (95%) OF G. SANGUINIS WAS OBTAINED. API 20 STREP, VITEK MS, AND 16S SEQUENCING ALL IDENTIFIED THE ORGANISM AS G. HAEMOLYSANS. THEREFORE, THE FINAL IDENTIFICATION IS G. HAEMOLYSANS. IN THIS CASE, THE CUSTOMER GP CARD LOT DID GIVE THE CORRECT ID OF G. HAEMOLYSANS AS PART OF THE LOW DISCRIMINATION CALL. ISOLATES 911425 AND 911427 ARE ATYPICAL STRAINS. FOR ISOLATE 911426, CARDS ARE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX A MISIDENTIFICATION OF GEMELLA MORBILLORUM AS GEMELLA SANGUINIS IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT ((B)(4)). THE CUSTOMER REPORTED THE ORGANISM WAS TWICE IDENTIFIED BY THE VITEK® 2 AS GEMELLA SANGUINIS. THE CUSTOMER REPORTED TESTING THE ORGANISM FOUR (4) TIMES WITH VITEK® MS AND THE RESULTS WERE: 1 - GEMELLA MORBILLORUM 99.9%. 2 - GEMELLA MORBILLORUM / HAEMOLYSANS 50%/50%. 3 - GEMELLA MORBILLORUM 99.9%. 4 - GEMELLA MORBILLORUM / GEMELLA HAEMOLYSANS 50%/50%. THE CUSTOMER STATED THE API VP TEST WAS NEGATIVE AND THE API 20STREP TEST IDENTIFIED GEMELLA HAEMOLYSANS. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317760 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST CARD LQL BIOMERIEUX, INC 2420071103

    Patients

    Seq Age Sex Outcome Treatment
    1