BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-GP78 TEST KIT

    MDR report key: 10551296 · Received September 17, 2020

    Report

    Report Number
    1950204-2020-00181
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    November 19, 2020
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026553982
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS PREVIOUSLY SUBMITTED FOLLOWING A NOTIFICATION FROM A UNITED STATES CUSTOMER REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS WHEN TESTING STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-GP78 TEST KIT. WHILE BIOMÉRIEUX WORKED WITH THE CUSTOMER TO INVESTIGATE THIS ISSUE, THE CUSTOMER HAD BEEN ASKED TO RETAIN AND SUBMIT ANY FUTURE S. AUREUS ISOLATES FOR WHICH THEY OBTAIN A FALSE POSITIVE OXSF RESULT. IN TOTAL, THE CUSTOMER REPORTED 24 PATIENT ISOLATES AND ONE (1) QC STRAIN WITH FALSE POSITIVE OXSF RESULTS. THEIR TESTING INCLUDING AST-GP78 CARDS FROM THREE (3) DIFFERENT LOTS. FOR THE CUSTOMER¿S FIRST IMPACTED LOT, AST-GP78 LOT 2781335403, 14 PATIENT ISOLATES AND ONE (1) QC STRAIN HAD FALSE POSITIVE OXSF RESULTS (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168). FOR AST-GP78 LOT 2781357203, SEVEN (7) PATIENT ISOLATES HAD FALSE POSITIVE OXSF RESULTS (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00181). FOR AST-GP78, LOT 2781427403 THREE (3) PATIENT ISOLATES HAD FALSE POSITIVE OXSF RESULTS (MDR 1950204-2020-00198 THROUGH 1950204-2020-00200). AS A REMINDER, BIOMÉRIEUX PREVIOUSLY NOTIFIED THE FDA VIA MEDWATCH REPORTS OF THE INTERMEDIATE RESULTS OF THIS INVESTIGATION, WHICH INCLUDED TESTING OF THE CUSTOMER¿S RETURNED SALINE AND UNUSED CARDS FROM LOT 2781335403 FOR EVIDENCE OF CONTAMINATION. NO EVIDENCE OF CONTAMINATION WAS NOTED. TESTING ALSO INCLUDED THE CUSTOMER'S RETURNED QC STRAIN (S. AUREUS ATCC 29213) AND THE INTERNAL BIOMÉRIEUX QC STRAIN (STOCK #694; ATCC 29213) AND WAS CONDUCTED ON THE CUSTOMER¿S RETURNED CARDS FROM AST-GP78, LOT 2781335403, RETAINED CARDS FROM CUSTOMER¿S FIRST AND SECOND LOTS (LOT 2781335403 AND LOT 2781357203), AND ALSO FROM A RANDOM LOT (2781173403). FOR ALL 32 CARDS TESTED, THE EXPECTED NEGATIVE OXFS RESULT WAS OBTAINED. THE CUSTOMER HAS SINCE SUBMITTED TWO ISOLATES ID 21692428 AND ID 21726837, THREE USED AST-GP78 CARDS FROM THE TESTING OF THESE ISOLATES, AND ANOTHER SAMPLE OF THEIR SALINE. STERILITY TESTING ON THE RETURNED SALINE LABELED "9/22" GREW BOTH KLEBSIELLA OXYTOCA AND PSEUDOMONAS AERUGINOSA ON TSAB AGAR AFTER 24 HOURS. ASPIRATION OF THE CEFOXITIN SCREEN WELL AND THE POSITIVE CONTROL (PC) WELL OF THE THREE (3) RETURNED CARDS TO TSAB AGAR WAS PERFORMED IN ADDITION TO A GRAM STAIN. THE CEFOXITIN SCREEN WELL SHOWED GRAM NEGATIVE RODS WHEN GRAM STAINED AND GREW PS. AERUGINOSA (IDENTIFIED VIA VITEK MS) AFTER 24 HOURS OF INCUBATION. THE PC WELL GRAM STAIN SHOWED GRAM POSITIVE COCCI IN ADDITION TO THE GRAM NEGATIVE RODS, WHICH WERE LATER IDENTIFIED AS S. AUREUS VIA VITEK MS. THE RETURNED ISOLATES (ID 21692428 AND ID 21726837) WERE TESTED ON AST-GP78 CARDS FROM LOTS 2781335403, 2781427403, 2781357203 AND 2781246203. ELEVEN CARDS WERE TESTED USING INTERNAL BIOMÉRIEUX SALINE WHILE EIGHT (8) CARDS WERE RAN USING THE CUSTOMER'S RETURNED SALINE FROM 29SEP2020. FOR ALL CARDS TESTED, A NEGATIVE CEFOXITIN SCREEN RESULT WAS OBTAINED. ADDITIONALLY, THE MANUAL CEFOXITIN DISK SCREEN WAS NEGATIVE FOR BOTH ISOLATES WHEN USING BOTH INTERNAL AND THE CUSTOMER'S RETURNED SALINE. BOTH ISOLATES ALSO HAD NEGATIVE CEFOXITIN BROTH MICRO DILUTION RESULTS. ADDITIONALLY, PBP2A TESTING WAS NEGATIVE FOR BOTH ISOLATES. FINALLY, VITEK 2 OXACILLIN (OX) MIC VALUES WERE SUSCEPTIBLE AND IN BOTH ESSENTIAL AND CATEGORICAL AGREEMENT WITH OX AGAR DILUTION AND BROTH MICRODILUTION TESTING. *IT SHOULD BE NOTED THAT THE CUSTOMER'S RETURNED CONTAMINATED SALINE HAD BEEN REFRIGERATED PRIOR TO TESTING IN ORDER TO PREVENT ADDITIONAL MICROBIAL GROWTH. ADDITIONALLY, TO BE NOTED, R&D REVIEWED CUSTOMER SUBMITTED RAW CARD DATA FOR ISOLATE 21692428 AND NOTED LATE GROWTH IN THE OXSF WELL (~13 HRS). EACH OF THE CUSTOMER¿S RETURNED S. AUREUS ISOLATES (ISOLATE 21726837 AND ISOLATE 21692428) AND EACH OF THE RECOVERED PS. AERUGINOSA IN THE OXSF WELL FROM ITS CORRESPONDING RETURNED AST-GP78 CARD WAS USED FOR FURTHER TESTING. IN ORDER TO SIMULATE CONTAMINATED SALINE, A 0.5 MCF SUSPENSION WAS CREATED FROM THE RECOVERED PS. AERUGINOSA WITH 3.0 ML OF INTERNAL STERILE SALINE AND THEN DILUTED VIA SERIAL DILUTIONS FROM ~1:300 (3X10^2) TO ~1:27,000,000 (2.7X10^7). NEXT, A 0.5 MCF SUSPENSION WITH THE CUSTOMER¿S S. AUREUS ISOLATES WERE PREPARED FROM STERILE SALINE. THE FOUR ¿CONTAMINATED¿ SALINE TUBES WERE THEN INOCULATED WITH THE STANDARD 280¿L (FOR GRAM POSITIVE ORGANISM VITEK 2 AST CARD TESTING) FROM THE 0.5 MCF S. AUREUS SUSPENSION. AN ADDITIONAL "NEGATIVE CONTROL" WITH STERILE SALINE WAS PREPARED IN A FIFTH TUBE AND INOCULATED WITH 280¿L FROM THE 0.5 MCF S. AUREUS SUSPENSION (PREPARED FROM THE CUSTOMER'S RETURNED S. AUREUS ISOLATES). FINALLY, A SIXTH TUBE WHOSE 0.5 MCF SUSPENSION WAS PREPARED WITH THREE COLONIES OF S. AUREUS AND ONE COLONY OF PS. AERUGINOSA WAS ALSO PREPARED IN ORDER TO MIMIC A MIXED PLATE CONTAMINATION. ALL CARDS CONTAINING A PS. AERUGINOSA CONTAMINANT RESULTED IN A POSITIVE OXSF RESULT WITH THE EXCEPTION OF TUBE #4 (1:2.7 X10^7) FROM ISOLATE 21692428 TESTING, WHICH RESULTED IN A NEGATIVE OXSF RESULT. NEGATIVE CONTROL TUBE #5 (STERILE SALINE WITH NO CONTAMINATION) RESULTED IN THE EXPECTED NEGATIVE OXSF RESULT AS WELL FOR BOTH ISOLATES. FINALLY, TUBE #6 WITH MIXED COLONY TYPES RESULTED IN A POSITIVE OXSF RESULT FOR BOTH ISOLATES TESTED. THIS TESTING REPLICATES THE CUSTOMER'S FALSE POSITIVE RESULTS. IN ADDITION TO THE ABOVE TESTING, A LOT REVIEW WAS PERFORMED FOR THE CUSTOMER¿S IMPACTED LOTS. AST-GP78 CARD, LOTS 2781335403, 2781357203 AND 2781427403 MET FINAL QC RELEASE CRITERIA. THE LOTS PASSED QC PERFORMANCE TESTING. A QC DATA REVIEW FOR ATYPICAL GROWTH WAS PERFORMED ON AST-GP78 LOTS 2781427403, 2781335403 AND 2781357203. THE SET OF NINE OXSF NEGATIVE QC STRAINS FOR THE OXSF TEST WAS TESTED WITH EACH LOT. A GRAPH REVIEW FOR ATYPICAL GROWTH WAS PERFORMED ON THESE LOTS VIA THE GRAPH WELL PROGRAM WITH THE NINE OXSF NEGATIVE QC STAPHYLOCOCCUS STRAINS. FOR THESE THREE AST-GP78 LOTS, THE REVIEW DISPLAYED NO ATYPICAL GROWTH FOR ANY OF THE NINE OXSF NEGATIVE STRAINS. AST-GP78 CARDS FROM LOT 2781357203 (49 CARDS) AND LOT 2781335403 (183 CARDS) WERE TESTED WITH OXSF NEGATIVE QC STRAIN #694 (ATCC #29213) PER PROCEDURES. THERE WERE NO FALSE POSITIVE RESULTS OBSERVED FOR AST-GP78 LOTS 2781357203 OR 2781335403 IN THE OXSF WELL 6 FOR ANY OF THE CARDS TESTED FROM THE CUSTOMER-SUPPLIED OR BIOMERIEUX-RETAINED CARDS. AS A RESULT, THERE IS NO EVIDENCE OF MANUFACTURING CONTAMINATION IN ANY OF THE CARDS TESTED FOR THIS INVESTIGATION. A REVIEW OF MANUFACTURED LONG TERM CEFOXITIN STOCKS DURING THE TIME FRAME OF 04JAN2019 THROUGH 17SEP2020 WAS PERFORMED AND IT WAS FOUND THAT THERE WAS NOT A CORRELATION OR COMMONALITY BETWEEN MANUFACTURED PRODUCTION LOTS AND CEFOXITIN SCREEN LONG TERM STOCK BATCHES WITH REGARDS TO COMPLAINTS. A MICROBIAL GROWTH EVALUATION OF CEFOXITIN LONG TERM STOCK AND CEFOXITIN ANTIBIOTIC POWDER WAS PERFORMED. CEFOXITIN POWDER WAS INOCULATED ON BLOOD AGAR PLATES AND INCUBATED AT 35C, 25C AND 40C FOR 24 HOURS AND 48 HOURS.. THE CEFOXITIN POWDER AND CEFOXITIN LONG TERM STOCK WAS ALSO SOLUBILIZED IN SALINE AND INOCULATED IN BACT/ALERT®AST CULTURE BOTTLES AND INCUBATED AT 35C FOR 24 AND 48 HOURS. THE CULTURES TESTED DID NOT GROW IN ANY OF THE CONDITIONS; THEREFORE, IT IS CONCLUDED THAT THERE IS NOT ANY BIOBURDEN PRESENT IN THESE SAMPLES. FINAL CONCLUSIONS: TO SUMMARIZE, THE CUSTOMER'S FALSE POSITIVE CEFOXITIN SCREEN RESULT WAS NOT DUPLICATED IN BIOMÉRIEUX INTERNAL LABS WHEN TESTING THE CUSTOMER'S SUBMITTED S. AUREUS QC AND PATIENT STRAINS OR THE INTERNAL BIOMÉRIEUX QC STRAIN WHEN FOLLOWING GUIDELINES OUTLINED IN THE PRODUCT INFORMATION MANUAL AND THE PACKAGE INSERT. THE CUSTOMER'S INITIAL RETURNED SALINE AND UNUSED CARDS FROM LOT 2781335403 DID NOT SHOW ANY INDICATION OF CONTAMINATION AS NO MICROBIAL GROWTH WAS NOTED FROM THE SALINE OR IN THE RETURNED UNUSED CARDS. THE CUSTOMER'S SECOND ROUND OF RETURNED MATERIALS DID INDICATE CONTAMINATION HAD OCCURRED AS PS. AERUGINOSA WAS RECOVERED FROM THE CUSTOMER'S RETURNED SALINE AND ALSO FROM THE RETURNED USED CARDS THAT WERE ASSOCIATED WITH ISOLATES 21692428 AND 21726837. ADDITIONAL TESTING INVOLVING THE CUSTOMER'S RETURNED S. AUREUS ISOLATES PREPARED IN SUSPENSIONS CONTAINING RECOVERED PS. AERUGINOSA FROM THEIR ASSOCIATED CARDS DID REPLICATE THE CUSTOMER'S FALSE POSITIVE RESULTS. ANALYSIS OF THE CUSTOMER'S SUBMITTED DATABASE BACKUP AND ANTIBIOGRAM SHOW THAT THE CUSTOMER'S FALSE POSITIVE RATE OF 1 TO 2 OCCURRENCES EVERY TWO WEEKS IS STILL BELOW FDA GUIDELINES AND BIOMÉRIEUX PUBLISHED PERFORMANCE CHARACTERISTICS. REVIEW OF THE CUSTOMER'S RETURNED RAW CARD DATA SHOWED LATE GROWTH IN THE OXSF WELL FOR THE FOUR ISOLATES THAT WERE ANALYZED. LATE GROWTH CAN BE INDICATIVE OF LOW LEVEL CONTAMINATION. FINALLY, SINCE COMMUNICATING WITH THE CUSTOMER THAT CONTAMINATION WAS DETECTED IN THEIR RETURNED SALINE, THE CUSTOMER HAS STATED THAT THEY HAVE COMPLETELY CHANGED OUT THEIR DISPENSETTE AND SALINE AND SINCE (APPROXIMATELY) (B)(6) 2020, THERE HAVE BEEN NO NEW CASES OF FALSE POSITIVE CEFOXITIN SCREENS.

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOLLOWING A REPORT FROM A UNITED STATES CUSTOMER REGARDING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS WHEN TESTING STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT (REF. 421051, LOT 2781357203). THE CUSTOMER INITIALLY REPORTED OBTAINING A FALSE POSITIVE OXSF RESULT FOR 14 STAPHYLOCOCCUS AUREUS PATIENT ISOLATES AS WELL AS ONE PACKAGE INSERT QC ORGANISM, S. AUREUS ATCC® 29213¿ WHEN TESTING WITH LOT 2781335403. THE CUSTOMER THEN STATED THAT AN ADDITIONAL SEVEN (7) S. AUREUS ISOLATES DEMONSTRATED NON-REPEATABLE FALSE POSITIVE VITEK 2 OXFS RESULTS WHEN TESTED WITH AST-GP78 TEST KIT, LOT 2781357203. RESULTS OF THE CURRENTLY ACTIVE INVESTIGATION ARE AS FOLLOWS. TROUBLESHOOTING INFORMATION TO DATE DID NOT IDENTIFY ANY OFF-LABEL USE. THE CUSTOMER STATED THAT ROUTINE SALINE STERILITY TESTING IS NOT PERFORMED, AND THERE'S A POSSIBILITY THAT ORGANISM SUSPENSIONS MAY HAVE BEEN SETUP OUTSIDE OF THE CULTURE REQUIREMENTS PARAMETERS LISTED IN THE INSTRUCTIONS FOR USE (EIFU). OF THE 21 REPORTED PATIENT ISOLATES, NONE WERE AVAILABLE FOR SUBMITTAL. VITEK 2 RAW DATA WERE AVAILABLE FOR ONLY THREE (3) OF THE ISOLATES. THE CUSTOMER SUBMITTED THEIR S. AUREUS ATCC 29213 QC STRAIN, AS WELL AS 11.5 BOXES OF CARDS FROM LOT 2781335403 AND THREE (3) CONICAL VIALS WITH SEVEN (7) MLS OF SALINE EACH FROM THE CUSTOMER'S SALINE BOTTLES. BIOMERIEUX HAS REQUESTED THAT THE CUSTOMER RETAIN AND SUBMIT ANY FUTURE S. AUREUS ISOLATES FOR WHICH THEY OBSERVE A FALSE POSITIVE OXSF. INTERNAL TESTING OF BIOMÉRIEUX QC STRAIN (STOCK # 694; ATCC 29213) AGAINST THE CUSTOMER'S INITIAL LOT (2781335403) AND A RANDOM LOT (2781427403) WAS PERFORMED IN DUPLICATE. FOR ALL FOUR (4) CARDS TESTED, THE EXPECTED NEGATIVE OXSF RESULT WAS OBTAINED. ADDITIONALLY, NO OTHER DISCREPANT QC REACTIONS WERE NOTED. THE CUSTOMER'S SALINE WAS INOCULATED TO BACT/ALERT® INDUSTRY BLOOD CULTURE BOTTLES, AND TO A TSAB BLOOD AGAR PLATE. NO GROWTH WAS OBSERVED IN ANY BOTTLES OR ON THE TSAB AGAR PLATE. SALINE BLANK (STERILE FILLS; NO ORGANISM) TESTING WAS CONDUCTED ON 35 OF THE CUSTOMER'S RETURNED CARDS. VITEK 2 POLYSTYRENE TUBES WERE INOCULATED WITH 3 MLS OF FRESH SALINE VIA A RECENTLY STERILIZED (AUTOCLAVED) DISPENSETTE. ALL CARDS APPROPRIATELY TERMINATED WITH "INSUFFICIENT GROWTH IN THE POSITIVE CONTROL WELL". R&D EXAMINED THE CORRESPONDING RAW DATA, AND NO GROWTH WAS OBSERVED IN THE OXSF WELL, FOR ANY OF THE CARDS. THE CUSTOMER'S SUBMITTED QC STRAIN WAS SUBCULTURED AND INCUBATED FOLLOWING IFU INSTRUCTIONS, AT 35-37C FOR 18-24 HOURS, IN AIR ATMOSPHERE, AND SPECIES IDENTIFICATION WAS CONFIRMED VIA VITEK MS AS STAPHYLOCOCCUS AUREUS. TESTING FROM A SECOND SUBCULTURE FROM THE CUSTOMER'S RETURNED QC STRAIN (S. AUREUS ATCC 29213) AS WELL AS FROM THE INTERNAL BIOMÉRIEUX QC STRAIN (STOCK #694; ATCC 29213) WAS CONDUCTED ON THE CUSTOMER¿S RETURNED CARDS FROM AST-GP78, LOT 2781335403, RETAINED CARDS FROM CUSTOMER¿S FIRST LOT 2781335403, AND THE SECOND LOT 2781357203, AND ALSO FROM A RANDOM LOT (2781173403) IN QUADRUPLICATE, FOR A TOTAL OF 32 CARDS TESTED. FOR ALL 32 CARDS TESTED, THE EXPECTED NEGATIVE OXFS RESULT WAS OBTAINED. THE INVESTIGATION IS STILL ACTIVE. BIOMÉRIEUX HAS BEEN ON SITE TO TROUBLESHOOT THE ISSUE WITH THE CUSTOMER AND REMAINS IN CONTACT TO OBTAIN FURTHER INFORMATION FOR CONTINUING THE INVESTIGATION, AS WELL AS ENCOURAGING THE SUBMITTAL OF ANY FUTURE STAPHYLOCOCCUS AUREUS ISOLATES FOR WHICH THEY OBTAIN A FALSE POSITIVE OXSF RESULT. THE FIELD APPLICATION SPECIALIST PROVIDED INSTRUCTION AS TO HOW TO RETRIEVE THE VITEK 2 CARD FROM THE INSTRUMENT, AND SUBMIT FOR ANALYSIS. SHE ALSO INSTRUCTED THE CUSTOMER ON THE IMPORTANCE OF OBSERVING PROPER INCUBATION TIMES PRIOR TO INOCULATING SAMPLES FOR IDENTIFICATION AND SUSCEPTIBILITY. THE CUSTOMER INDICATED THAT THERE WERE NO TRENDS REGARDING THEIR SUSPECTED SAMPLES, I.E. WORK SHIFT, LOCATION, TECHNOLOGIST. THIS CUSTOMER HAS NOTIFIED BIOMÉRIEUX THAT THERE MAY BE DELAYS OR UNKNOWN IMPACTS DUE TO THE LOCAL WILDFIRES IN ADDITION TO THE COVID-19 PANDEMIC. A FINAL SUMMARY FOR THIS INVESTIGATION SHALL BE PROVIDED UPON COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMERIEUX OF OBTAINING FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN (OXSF) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH VITEK® 2 AST-GP78 TEST KIT 20 CARDS (REF. 421051, LOT 2781357203). THIS SAME CUSTOMER HAD PREVIOUSLY NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE OXSF RESULTS WHILE TESTING S. AUREUS WITH AST-GP78 LOT 2781335403 (MDRS 1950204-2020-00154 THROUGH 1950204-2020-00168 WERE SUBMITTED FOR THAT INCIDENT). THE CUSTOMER SWITCHED TO LOT 2781357203 AND NOTICED A DECREASE IN FALSE POSITIVE OXSF RESULTS, HOWEVER, THE DISCREPANT RESULTS STILL OCCURRED. THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE CEFOXITIN SCREEN RESULTS WITH FOUR (4) ISOLATES (MDRS 1950204-2020-00175 THROUGH 1950204-2020-00178 WERE SUBMITTED FOR THOSE ISOLATES). AN ON-SITE FIELD APPLICATION SPECIALIST (FAS) VISIT FOR TROUBLESHOOTING WAS COMPLETED INCLUDING A REVIEW OF THE CUSTOMER¿S SETUP PROCEDURES. NO OFF-LABEL USE OR USER SETUP ERRORS HAVE BEEN NOTED FOR THIS CUSTOMER. THE CUSTOMER NOTIFIED BIOMÉRIEUX OF THREE (3) MORE ISOLATES IMPACTED BY THIS ISSUE WITH LOT 2781357203 DURING THIS ON-SITE VISIT. SUMMARY: VITEK 2 AST-GP78, LOT 2781357203. S. AUREUS, ISOLATE 21505134; INITIAL: OXSF=POSITIVE / OXACILLIN (OX)=0.5, R*; REPEAT: OXSF=NEGATIVE / OX=0.5, S; EXPECTED: OXSF=NEGATIVE. S. AUREUS, ISOLATE 21493369; INITIAL: OXSF=POSITIVE / OX=0.5, R*; REPEAT: NOT PERFORMED; EXPECTED: OXSF=NEGATIVE. S. AUREUS, ISOLATE 21450269; INITIAL: OXSF=POSITIVE / OX=0.5, R*; REPEAT: OXSF=NEGATIVE / OX=0.5, S; EXPECTED: OXSF=NEGATIVE. DENOTES AN AES (ADVANCED EXPERT SYSTEM¿) THERAPEUTIC CORRECTION FROM SUSCEPTIBLE TO RESISTANT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A COMPLAINT INVESTIGATION IS ACTIVELY UNDERWAY. BIOMERIEUX¿S GLOBAL CUSTOMER SERVICE UNIT HAVE CONTACTED THE CUSTOMER WITH REGARDS TO THE INVESTIGATION AND HAVE REQUESTED CASE SPECIFIC CUSTOMER DATA TO AID THE INVESTIGATION. THE CUSTOMER NO LONGER HAD THESE THREE (3) ISOLATES TO SUBMIT FOR THE INVESTIGATION. A COMPLAINT TREND REVIEW FOR ALL AST LOTS VERSUS FALSE POSITIVE OXSF FOR STAPHYLOCOCCUS AUREUS WAS PERFORMED, AND THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST A NEW EMERGING ISSUE WITH THE CEFOXITIN SCREEN TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010994 VITEK 2 AST-GP78 TEST KIT VITEK® 2 AST-GP78 TEST KIT LON BIOMERIEUX, INC. 2781357203 03573026553982

    Patients

    Seq Age Sex Outcome Treatment
    1