RAPIDEC CARBA NP (10) - 415418

Additional Manufacturer Narrative

A CUSTOMER IN COLOMBIA NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED POSITIVE RESULTS ON SEVEN PATIENT SAMPLES OF PSEUDOMONAS AERUGINOSA IN ASSOCIATION WITH RAPIDEC® CARBA NP (REF. (B)(4), LOT# 1008199550). THE CUSTOMER SUSPECTED THE RESULTS WERE INCORRECT AS EACH SAMPLE GAVE NEGATIVE RESULTS WITH PCR METHOD. INVESTIGATION BIOMÉRIEUX RETAINS SAMPLES OF EVERY LOT NUMBER RELEASED TO THE MARKET. RETAINED SAMPLES FOR THE IMPACTED LOT NUMBER (#1008199550) WERE TESTED IN PARALLEL WITH ONE INTERNAL LOT NUMBER (LOT# 1008586780) USED AS REFERENCE. THE TESTS WERE PERFORMED USING THE QUALITY CONTROL (QC) STRAINS KLEBSIELLA PNEUMONIAE ATCC® BAA 1705¿, KLEBSIELLA PNEUMONIAE ATCC® BAA 1706¿ AND KLEBSIELLA PNEUMONIAE ATCC® 700603¿ (STRAINS INCLUDED IN THE PACKAGE INSERT). ALL THE RESULTS WERE IN ACCORDANCE WITH THE SPECIFICATIONS. NO DIFFERENCE IN RESULTS WAS OBSERVED BETWEEN THE LOT 1008199550 RELATED TO THE COMPLAINT AND THE REFERENCE LOT. THE BATCH RECORD FOR LOT NUMBER 1008199550 HAS BEEN VERIFIED. NONCONFORMITIES DURING THE MANUFACTURING AND QUALITY CONTROL PROCESSES WERE NOT OBSERVED. A COMPLAINT SEARCH ON LOT NUMBER 1008199550 REVEALED NO OTHER REPORTS WERE REGISTERED FOR THIS LOT NUMBER. CONCLUSION THE RESULTS OF QUALITY CONTROL OBTAINED DURING OUR INVESTIGATION ON THE IMPACTED RAPIDEC® CARBA NP COMPLIED WITH SPECIFICATIONS. THE BATCH RECORD ANALYSIS DID NOT SHOW NON-CONFORMITY DURING MANUFACTURING AND QUALITY CONTROL PROCESSES. THE TREND ANALYSIS OF THE COMPLAINTS DID NOT SHOW ANY DEVIATION ON THE PRODUCT. THE SEVEN PSEUDOMONAS AERUGINOSA PATIENT STRAINS ARE NOT AVAILABLE, THUS NO FURTHER INVESTIGATION IS POSSIBLE. INVESTIGATION DID NOT IDENTIFY PRODUCT PERFORMANCE ISSUE, SO NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED.

Description of Event or Problem

PRODUCT INTENDED USE: THE RAPIDEC® CARBA NP TEST CONSISTS OF A READY-TO-USE STRIP FOR THE RAPID DETECTION OF CARBAPENEMASE-PRODUCING, ENTEROBACTERIACEAE, PSEUDOMONAS AERUGINOSA AND ACINETOBACTER BAUMANNII, USING BACTERIA CULTURED ON AN AGAR MEDIUM. DESCRIPTION OF THE ISSUE: A CUSTOMER FROM (B)(6) REPORTED THAT HE OBTAINED FALSE POSITIVE RESULTS WHEN TESTING PSEUDOMONA AERUGINOSA PATIENT STRAINS WITH RAPIDEC CARBA NP TEST (REF. 415418) ¿ LOT 1008199550. THE CUSTOMER REPORTED HE OBTAINED POSITIVE RESULTS FOR SEVEN (7) STRAINS OF PSEUDOMONAS AERUGINOSA WITH THE RAPIDEC CARBA NP TEST WHILE RESULTS WERE NEGATIVE USING MOLECULAR METHODS. THERE IS NO INFORMATION FROM THE CUSTOMER INDICATING THAT THIS EVENT LED TO A DELAY OF RESULTS OR IMPACTED ANY PATIENT'S STATE OF HEALTH.