BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P654 TEST KIT

    MDR report key: 8620296 · Received May 17, 2019

    Report

    Report Number
    1950204-2019-00144
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K# N50510: S117.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED IN RESPONSE TO A CUSTOMER COMPLAINT FOR A FALSE RESISTANT OXACILLIN (OX) RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P654 TEST KIT (REF 421912, LOT 8040900103). THE CUSTOMER PROVIDED THE STRAIN FOR INVESTIGATIONAL TESTING. THE STRAIN WAS VERIFIED TO BE STAPHYLOCOCCUS AUREUS USING THE VITEK® 2 GP ID TEST KIT (LOT 2420906203). INVESTIGATIONAL TESTING INCLUDED TESTING THE STRAIN USING REFERENCE METHODS AS WELL AS ANALYZING THE STRAIN USING THE VITEK® 2 AST-P654 TEST KIT FROM THE CUSTOMER'S LOT (8040900103) AND A RANDOM LOT (8040873203). ----REFERENCE TEST RESULTS:---- PCR MECA/MECC = NEG AGAR DILUTION (AD): OX MIC - 0.25 MG/L (SUSCEPTIBLE) KIRBY-BAUER CEFOXITIN (FOX KB): D = 25 MM (SUSCEPTIBLE) ----VITEK® 2 AST-P654 RESULTS---- CUSTOMER'S LOT (8040900103): OX MIC = 0.5 MG/L (SUSCEPTIBLE) CEFOXITIN SCREEN (OXSF) = NEG (SUSCEPTIBLE) RANDOM LOT (8040873203) OX MIC = 0.5 MG/L (SUSCEPTIBLE) CEFOXITIN SCREEN (OXSF) = NEG (SUSCEPTIBLE) ----CONCLUSIONS---- THE OX AND OXSF RESULTS OBTAINED FROM VITEK® AST-P654 TESTING ARE IN AGREEMENT WITH THE REFERENCE METHODS. THE CUSTOMER'S RESISTANT OXACILLIN RESULTS ON AST-P654 CARD WERE NOT REPRODUCED INTERNALLY. THE VITEK® 2 AST P654 TEST KIT CARDS ARE PERFORMING AS EXPECTED. VITEK® 2 AST-P654 TEST KIT LOT 8040900103 MET FINAL QC RELEASE CRITERIA. THE LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE RESISTANT OXACILLIN RESULT FOR A PATIENT STAPHYLOCOCCUS AUREUS ISOLATE WHILE USING THE VITEK® 2 AST-P654 TEST KIT (REF # (B)(4), LOT# 8040900103). THE ISOLATE WAS REPEATED ON THE VITEK 2 WITH THE SAME LOT OF CARDS AND WAS ALSO TESTED USING ALTERNATE TEST METHODS CEFOXITIN DISK DIFFUSION AND MECA/MECC PCR. THE RESULTS ARE LISTED BELOW: ORIGINAL VITEK 2 RESULT: OXACILLIN MINIMUM INHIBITORY CONCENTRATION (MIC) >2, CEFOXITIN SCREEN (B)(6) - RESISTANT. REPEAT VITEK 2 RESULT: OXACILLIN MIC= 0.5, CEFOXITIN SCREEN (B)(6) - SENSITIVE. CEFOXITIN DISK DIFFUSION RESULT: 29MM - SENSITIVE . MECA/MECC PCR RESULT: (B)(6) . THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE DISCREPANT RESULT. NO WRONG RESULT WAS REPORTED. THE CUSTOMER STATED THERE WAS NO DELAY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413448 VITEK® 2 AST-P654 TEST KIT VITEK® 2 AST-P654 TEST KIT LON BIOMERIEUX, INC. 8040900103

    Patients

    Seq Age Sex Outcome Treatment
    1