Description of Event or Problem · 1
BIOMERIEUX WAS CONTACTED BY (B)(4) REGULATORY AGENCY, ANSM, TO REPORT A DISCREPANT CEFOTAXIME RESULT (FALSE RESISTANT) FOR PROTEUS PENNERI (FROM A BONE SAMPLE) ON THE VITEK 2 AST-N234 TEST KIT. THE RESULT PROVIDED BY THE VITEK 2 (INITIAL TEST AND REPEAT TEST) WAS CEFOTAXIME MIC >64MG/L (R). CONFIRMATION VIA ETEST METHOD INDICATED CEFOTAXIME MIC = 1MG/L (S). PRIOR TO REPORTING RESULTS TO THE TREATING PHYSICIAN, THE PATIENT SAMPLE WAS RETESTED ON THE VITEK 2 AND CONFIRMATORY TEST WAS COMPLETED VIA ETEST. THE DISCREPANT VITEK 2 RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN; HOWEVER, THERE WAS A 48 HOUR DELAY IN REPORTING RESULTS TO THE TREATING PHYSICIAN SINCE TESTING HAD TO BE REPEATED AND CONFIRMED. THE GROWTH MEDIA USED FOR THE INITIAL VITEK 2 TEST WAS DRIGALSKI; FOR THE SECOND VITAK 2 TEST, CPS. DRIGALSKI MEDIA HAS NOT BEEN VALIDATED FOR USE WITH THE VITEK 2 TEST KITS. THE CUSTOMER STATED THE PATIENT'S THERAPY WAS NOT MODIFIED FOLLOWING THE RECEIPT OF THE TEST RESULT (CEFOTAXIME MIC = 1MG/L S) BY THE CLINICIAN. THE CUSTOMER INDICATED THAT ALTHOUGH REPORTING OF THE RESULT WAS DELAYED BY 48 HOURS, THERE WAS NO ADVERSE IMPACT TO THE PATIENT. BASED ON THE DETAILS PROVIDED BY THE CUSTOMER, THERE IS NO EVIDENCE/INDICATION OF THE FOLLOWING: INJURY OR DEATH TO PATIENT, EVIDENCE THAT A PATIENT UNDERWENT ANY UNNECESSARY MEDICAL PROCEDURE DUE TO THE REPORTED EVENT, PHYSICIAN ALLEGING THE REPORTED EVENT CAUSED HIM/HER TO PROVIDE INCORRECT TREATMENT, EVIDENCE OF NEGATIVE IMPACT TO THE PATIENT DUE TO THE FALSE RESISTANT VITAK 2 RESULT. THIS EVENT IS REPORTABLE AS AN ADVERSE EVENT, AS THE REPORTING OF THE FINAL AST (CEFOTAXIME) RESULT WAS DELAYED FOR 48 HOURS. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE FALSE RESISTANT CEFOTAXIME RESULT LED TO AN ADVERSE EVENT RELATED TO THE PATIENT STATE OF HEALTH. INTERNAL COMPLAINT INVESTIGATION IS IN PROGRESS. THIS WILL BE UPDATED AS FURTHER INFORMATION BECOMES AVAILABLE.