BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 NH ID TEST KIT

    MDR report key: 6804092 · Received August 18, 2017

    Report

    Report Number
    1950204-2017-00270
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Report Date
    December 21, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    JST
    UDI-DI
    03573026144357
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: NO INFORMATION WAS PROVIDED CONCERNING THE CUSTOMER'S SET UP PROCEDURE. FOURTEEN (14) LABORATORY REPORTS WERE ATTACHED TO THE COMPLAINT RECORD OF WHICH SEVEN (7) WERE DUPLICATES. FIVE (5) LAB REPORTS (72476, 73387, 74087, 74582, AND 75744) SHOWED A RESULT OF VERY GOOD N. CINEREA WITH SIX (6) ATYPICAL NEGATIVE REACTIONS (PYRA, ODC, LGLM, PVATE, OPS, DMLT) FOR AN IDENTIFICATION OF C. JEJUNI ACCORDING TO THE NH KNOWLEDGE BASE. TWO (2) LABORATORY REPORTS (72431 CAMPY, 72431 C JEJUNI) SHOWED A RESULT OF UNIDENTIFIED ORGANISM. THE FIRST LABORATORY REPORT SHOWED SEVEN (7) ATYPICAL REACTIONS (ATYPICAL NEGATIVE: ODC, LGLM, DMLT AND ATYPICAL POSITIVE: MTE, DMNE, NAG, DGLU) AND THE SECOND LABORATORY REPORT SHOWED EIGHT (8) ATYPICAL REACTIONS (ATYPICAL NEGATIVE: ODC, LGLM, PVATE, OPS, DMLT; ATYPICAL POSITIVE: MTE, DMNE, NAG) FOR AN IDENTIFICATION OF C. JEJUNI ACCORDING TO THE NH KNOWLEDGE BASE. AN INCREASED NUMBER OF ATYPICAL POSITIVE REACTIONS CAN INDICATE CONTAMINATION, MIXED CULTURE, USE OF NON-RECOMMENDED MEDIA OR OTHER USER SET UP ERRORS OR AN ATYPICAL STRAIN. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. WITHOUT THE STRAIN OR RAW DATA IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. NH LOT #2450221203 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF MISIDENTIFICATION FOR CAMPYLOBACTER JEJUNI AS NEISSERIA CINEREA OR UNIDENTIFIED ORGANISM IN ASSOCIATION WITH VITEK® 2 NH ID TEST KIT, LOT 2450221203. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583628 VITEK® 2 NH ID TEST KIT VITEK® 2 NH ID TEST KIT JST BIOMERIEUX INC. 2450221203 03573026144357

    Patients

    Seq Age Sex Outcome Treatment
    1