CHROMID® STREPTO B AGAR

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) REPORTED THE OCCURRENCE OF NO GROWTH (RESULT NEGATIVE) FOR STREPTOCOCCUS AGALACTIAE IN ASSOCIATION WITH THE CHROMIDTREPTO B AGAR. THE SPECIMEN WAS A VAGINAL SAMPLE; NO ENRICHMENT, DIRECT ISOLATION ON PLATE AND INCUBATION TO 18, 24 AND 48 HOURS AT 37 DEGREES CELSIUS. THERE WAS NO GROWTH AFTER 48 HOURS INCUBATION. THE STRAIN EXHIBITED GROWTH ON CNA BLOOD AGAR AND THE ORGANISM WAS IDENTIFIED AS STREPTOCOCCUS AGALACTIAE VIA VITEK 2 GP ID TEST KIT.. THE CHROMID STREPTO B INSTRUCTIONS FOR USE (PACKAGE INSERT, LIMITATIONS OF THE METHOD) INDICATES: "GROWTH DEPENDS ON THE REQUIREMENTS OF EACH INDIVIDUAL MICRO-ORGANISM. IT IS THEREFORE POSSIBLE THAT CERTAIN STRAINS OF S. AGALACTIAE WHICH HAVE SPECIFIC REQUIREMENTS (SUBSTRATE, TEMPERATURE, INCUBATION CONDITIONS, ETC.) MAY NOT DEVELOP. ACCORDING TO THE SPECIMENS ANALYZED, A NON-SELECTIVE BLOOD AGAR MAY BE USED IN CONJUNCTION". IN ADDITION, AN ENRICHMENT STEP, NOT USED BY THE CUSTOMER IN THIS CASE, CAN INCREASE THE RATE OF RECOVERY OF STREPTOCOCCUS AGALACTIAE FOR STRAINS OBTAINED FROM PREGNANT WOMEN. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE OCCURRENCE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL IS NOT AVAILABLE FROM THE CUSTOMER. BIOMERIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED DUE TO A FALSE NEGATIVE RESULT (COLOR OF COLONIES NOT CHARACTERISTIC) ON THE CHROMID STREPTO B 20PLT, REF 43461, BATCH (B)(4), WITH AN EXPIRATION DATE OF 16NOV2016. THE CUSTOMER OBSERVED, AFTER ENRICHMENT IN TODD HEWITT BROTH OF A VAGINAL SWAB, BLUES COLONIES AFTER 24 H AND 48 H OF INCUBATION AT 37°C. HE USED IN PARALLEL COLUMBIA CNA MEDIUM ON WHICH GREW BACTERIA IDENTIFIED BY LATEX AND VITEK 2 , AS A STREPTOCOCCUS AGALACTIAE. THE IDENTIFICATION REPORT OF THIS STRAIN WAS NOT AVAILABLE. THE HOUR OF THE INCRIMINATED PLATE PROCESSED BY THE CUSTOMER IS 23H52. THE INVESTIGATION CONSISTED OF A BATCH RECORD AND COMPLAINT REVIEW, AND AN ANALYSIS OF THE BIOMÉRIEUX RETAINED REFERENCES SAMPLES. NO ANALYSIS WAS PERFORMED ON THE CUSTOMER STRAIN BECAUSE IT WAS NOT AVAILABLE. AS OF 20DEC216, THE COMPLAINT RECORD REVIEW INDICATES NO OTHER COMPLAINT HAVE BEEN REGISTERED FOR THIS BATCH FOR THE SAME ISSUE. THE INCRIMINATED BATCH WAS MANUFACTURED THE 03AUG2016 ON LINE A3 OF PETRI 1. NO DISCREPANCIES WERE DETECTED DURING THE MANUFACTURING. BACTERIOLOGICAL ANALYSIS WAS PERFORMED ON THE RETAINED SAMPLES OF THE INCRIMINATED BATCH (HOUR OF THE PLATE FROM THE RETAINED SAMPLE : 23H53). INOCULATION OF THE RETAINED SAMPLE OF INCRIMINATED BATCH OF CHROMID STREPTO B 20PLT, AND OF A REFERENCE BATCH OF CHROMID STREPTO B 20PLT (BATCH (B)(4) EXPIRATION DATE 08NOV2016), WAS PERFORMED USING THE QC METHOD WITH THE CQ STRAINS. IN PARALLEL, A BATCH OF GTS (43011, BATCH (B)(4) EXPIRY DATE 26JAN2017) WAS USED FOR CONTROL. WE OBTAINED THE FOLLOWING RESULTS : - GOOD GROWTH OF PINK TO RED COLONIES FOR THE STRAINS S.AGALACTIAE ATCC 12386 AND NCTC 8190 - INHIBITION FOR THE OTHER STRAINS (E.COLI ATCC 12386, S.AUREUS ATCC 6538 AND C.ALBICANS ATCC 10231) RESULTS ARE IN ACCORDANCE WITH OUR SPECIFICATIONS AND EQUIVALENT BETWEEN BOTH BATCHES OF CHROMID STREPTO B 20PLT. THIS INVESTIGATION CONCLUDED THAT PERFORMANCE OF CHROMID STREPTO B 20PLT, REF 43461 BATCH (B)(4) IS WITHIN SPECIFICATIONS. THE DEFECT OBSERVED BY THE CUSTOMER HAS NOT BEEN REPRODUCED WITH THE QC STRAINS ON OUR RETAINED SAMPLE WHOSE HOUR OF MANUFACTURING ARE ALMOST IDENTICAL TO THE INCRIMINATE PLATE (23H52 AND 23H53). THE REVIEW OF BATCH RECORD DID NOT CORRELATE WITH THE ISSUE OBSERVED BY THE CUSTOMER. NO IDENTIFICATION WAS PERFORMED ON THE BLUE COLONIES, THEREFORE IT IS NOT CERTAIN THAT THE STRAIN GIVEN BLUE COLONIES IS THE SAME AS THE ONE IDENTIFIED AS STREPTOCOCCUS AGALACTIAE ON CNA MEDIUM. WITHOUT THE IDENTIFICATION REPORT AND CUSTOMER'S STRAIN FOR CHARACTERIZATION, IT IS NOT POSSIBLE TO CONTINUE THE INVESTIGATION.