BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GP TEST KIT

    MDR report key: 6375853 · Received March 3, 2017

    Report

    Report Number
    1950204-2017-00076
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Report Date
    July 12, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LQL
    PMA / PMN Number
    K952095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF A MISIDENTIFICATION OF STREPTOCOCCUS DYSGALACTIAE AS STREPTOCOCCUS AGALACTIAE IN ASSOCIATION WITH THE VITEK® 2 GP IDENTIFICATION TEST KIT (CARD). THE CUSTOMER SUBMITTED THE PATIENT ISOLATE FOR INVESTIGATIONAL TESTING. VITEK® 2 GP ID CARD LOTS 2420136103 AND 2420157103 MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED ON INITIAL QC PERFORMANCE TESTING. THERE WERE NO NCMRS WRITTEN AGAINST THESE LOTS. NCMRS WERE REVIEWED FOR THE LAST 13 MONTHS AND THERE WERE NONE WRITTEN FOR MISIDENTIFICATIONS ON THE GP PRODUCT LINE. INVESTIGATIONAL TESTING INCLUDED: REFERENCE METHOD (SEQUENCING SODA) - ORGANISM IDENTIFICATION TO STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS API® 20 STREP - ORGANISM IDENTIFICATION TO STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS VITEK® 2 GP ID CARDS (TWO CUSTOMER LOTS 24201136103 AND 2420157103): 24201136103 - EXCELLENT IDENTIFICATION TO STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS (99%). 2420157103 - OBTAINED DIFFERENT RESULT ON TWO DIFFERENT CARDS; EXCELLENT IDENTIFICATION TO STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS (99%), AND EXCELLENT IDENTIFICATION TO STREPTOCOCCUS AGALACTIAE (99%). THE INVESTIGATION REPRODUCED THE DISCREPANT CUSTOMER RESULT ON 1/3 GP ID CARDS. THE ORGANISM STRAIN IS NOT REPRODUCIBLE. THE INVESTIGATION CONCLUDED THE ISOLATE SUBMITTED ISOLATES HAS AN ATYPICAL BIOCHEMICAL PROFILE; THERE IS NO EVIDENCE TO SUGGEST THE VITEK® 2 GN ID CARD IS PERFORMING OUTSIDE OF SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF STREPTOCOCCUS DYSGALACTIAE AS STREPTOCOCCUS AGALACTIAE FOR A THROAT (ANGINE) SAMPLE, IN ASSOCIATION WITH THE VITEK® 2 GP TEST KIT. THE CUSTOMER REPORTED THE VITEK® 2 TWICE IDENTIFIED THE SAMPLE AS STREPTOCOCCUS AGALACTIAE (99%), AND THE VITEK MS® IDENTIFIED STREPTOCOCCUS DYSGALACTIAE (= STREPTO C). THE CUSTOMER STATED THE INCORRECT IDENTIFICATION WAS REPORTED TO THE CLINICIAN AND THERE WAS NO IMPACT TO THE PATIENT OR TREATMENT. THERE WAS A DELAY GREATER THAN 24 HOURS FOR REPORTING RESULTS TO THE CLINICIAN. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160603 VITEK® 2 GP TEST KIT VITEK® 2 GP TEST CARD LQL BIOMERIEUX, INC 2420136103

    Patients

    Seq Age Sex Outcome Treatment
    1