BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 AST-P592 TEST KIT

    MDR report key: 7797445 · Received August 20, 2018

    Report

    Report Number
    1950204-2018-00288
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECT LOT NUMBER IS 3720669403.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED DUE TO A FALSE POSITIVE CEFOXITIN SCREEN TEST (OXSF) RESULTS FOR EIGHT (8) STAPHYLOCOCCUS AUREUS STRAINS (S1-S8) FROM PATIENT ISOLATES ASSOCIATED WITH VITEK®2 AST-P592 TEST KIT 20 CARDS ( LOT 720669403) AND VITEK®2 SYSTEM SOFTWARE VERSION 8.01. THE ABSENCE OF (B)(6) STRAINS WAS CONFIRMED BY PCR MECA/MECC NEGATIVE AND SUSCEPTIBLE CEFOXITIN DISC DIFFUSION RESULTS FOR ALL STRAINS EXCEPT FOR S2 WHICH IS CONFIRMED AS A (B)(6) STRAIN (MECA (B)(6); FOX KB R). TESTS WERE PERFORMED ON THE AST-P592 CARD AND SYSTEM VITEK 2 V8.01(AES PARAMETERS : GLOBAL EUROPEAN BASED + PHENOTYPIC). TWO AST-P592 CARDS (ONE FROM THE CUSTOMER LOT # 3720669403,CL AND ONE FROM A RANDOM LOT # 3720613103, RL) WERE TESTED FROM CBA (COS BMX) SUBCULTURES UNDER CO2 ATMOSPHERE. FOR S2 : POSITIVE OXSF TEST AND "MODIFICATION OF PBP (MECA)" PHENOTYPE GIVEN BY AES ON BOTH LOTS TESTED FOR ALL THE OTHERS STRAINS : NEGATIVE OXSF TESTS AND "WILD" OR "ACQUIRED PENICILLINASE" PHENOTYPES GIVEN BY AES ON BOTH LOTS TESTED. THESE OXSF TESTS RESULTS ARE CORRELATED WITH THE DISC DIFFUSION RESULT FOR ALL STRAINS. CONCLUSION: THE CUSTOMER'S FALSE OXSF POSITIVE RESULTS ARE NOT REPRODUCED INTERNALLY FOR S1, S3, S4, S5, S6, S7 AND S8. STRAIN S2 IS CONFIRMED AS A (B)(6) STRAIN AND THE VITEK POSITIVE OXSF RESULT IS THEN CORRECT AND IN AGREEMENT WITH THE DISC DIFFUSION RESULT AND PCR. THE VITEK 2 AST-P592 CARD PERFORMS AS EXPECTED AND NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION PERFORMED FOR FALSE POSITIVE CEFOXITIN SCREEN TESTS WITH STAPHYLOCOCCUS AUREUS: A REVIEW OF THE RAW MATERIALS, IN-PROCESS MATERIALS, AND THE MANUFACTURING PROCESSES DID NOT SHOW ANY LOT SPECIFIC FACTOR THAT COULD CAUSE AN INCREASE FALSE POSITIVES. THERE IS NO EVIDENCE OF AN INSTRUMENT PERFORMANCE OR MAINTENANCE ISSUE, PRODUCT STABILITY, NOR A MEASUREMENT OR STANDARDIZATION ISSUE. ALTHOUGH THE SOFTWARE VERSION 8.01 INCREASES THE READING TIME AND THEORETICALLY COULD INCREASE THE FALSE POSITIVE RATE, STUDIES SHOW THE RATE IS WELL WITHIN PERFORMANCE REQUIREMENTS. IT SHOULD ALSO BE NOTED THAT A CERTAIN DEGREE OF ORGANISM VARIABILITY CAN LEAD TO FALSE POSITIVE CEFOXITIN SCREEN RESULTS. THESE DEVIATIONS ARE CAPTURED IN THE PERFORMANCE CHARACTERISTICS OF THE CEFOXITIN SCREEN TEST. A REVIEW OF THE TEST METHOD IDENTIFIED RISKS FOR CONTAMINATION ASSOCIATED WITH ANCILLARY COMPONENTS USED IN THE TEST METHOD THAT CAN CAUSE FALSE POSITIVES AND WAS SHOWN TO BE THE CASE IN PREVIOUS INVESTIGATIONS. THE 8.01 CEFOXITIN SCREEN ANALYSIS MODIFICATION MAY HEIGHTEN THE IMPACT OF CONTAMINATION. FINALLY, A HEIGHTENED AWARENESS IN THE FIELD DUE TO MULTIPLE FIELD COMMUNICATIONS INVOLVING 8.01 AND CEFOXITIN SCREEN TESTING , MAY HAVE RESULTED IN AN INCREASED RATE OF COMPLAINTS EVEN IF THE OVERALL FALSE RESISTANCE RATE WAS THE SAME. THE COMPLAINT RATE WILL CONTINUE TO BE MONITORED AND ANY ADVERSE TREND WILL BE INVESTIGATED. IN ADDITION TO THE TESTING DONE BY BIOMÉRIEUX INVESTIGATORS, IT SHOULD BE NOTED THAT TO THIS POINT, NO CUSTOMER ISOLATE SUBMITTALS HAVE GENERATED THE SAME INITIAL FALSE POSITIVE OXSF RESULT. FURTHERMORE, THE FALSE POSITIVE RESULTS ARE NOT REPLICATED AT EITHER BIOMERIEUX OR AT THE CUSTOMER SITES. GCS (GLOBAL CUSTOMER SERVICE) INFO 4040, GOOD VITEK®2 TESTING PRACTICES WAS PUBLISHED 25SEP2018 IN ORDER TO ASSIST LCS (LOCAL CUSTOMER SERVICE) WITH CUSTOMER TROUBLESHOOTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED (B)(6) RESULTS FOR (B)(6) STRAINS FROM PATIENT ISOLATES (SOURCE: THROAT, WOUND, SURFACE SWABS, URINE) ASSOCIATED WITH VITEK®2 AST-P592 TEST KIT 20 CARDS ( LOT 720669403) AND VITEK®2 SYSTEM SOFTWARE VERSION 8.01. THE CUSTOMER STATED THAT THE STRAINS HAD A (B)(6) CEFOXITIN SCREEN TEST (OXSF). THE CUSTOMER PROVIDED THE TEST RESULTS FOR ONE ISOLATE: (B)(6). THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT TREATMENT. THERE WAS A DELAY GREATER THAN 24 HOURS IN REPORTING RESULTS DUE TO RETESTING. 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
    638441 VITEK®2 AST-P592 TEST KIT VITEK®2 AST-P592 TEST KIT LON BIOMERIEUX, INC. 3720669403

    Patients

    Seq Age Sex Outcome Treatment
    1