MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT® SN CULTURE BOTTLE

Catalog Number	259794
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of false negative results associated with bact/alert® sn culture bottle (reference 259790).The customer reported that two products (reference numbers 259790 and 259794) failed quality control (qc) testing at the same time while other bottles passed the same testing.There is not patient associated with this quality control testing.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
Biomérieux conducted an internal investigation: on 24sep18, review of the manufacturing directions (md) was conducted by the investigator at the durham, nc facility.The review encompassed an evaluation of the bact/alert® pf filling lot 1049786, labeling and packaging (finished product lot 1049787), and processes and inspections.The review included a review of the complete bottle form, rack/stack inspection form, and packaging defect log.All inspections met attribute limits.The lot met all quality finished goods release criteria.Instruction for use bact/alert® pf ifu 9311988 c-2016-03, was reviewed by the investigator on 23aug18.The ifu contains the following information regarding.Intended use bact/alert® pf culture bottles are used with the bact/alert® microbial detection system in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.Performance characteristics of the test - table 1 gram negative (e.Coli) with an inoculum of <=100 ( cfu/bottle) time to detection 10.4-39.8 hours and with an inoculum of <=10 ( cfu/bottle) time to detection 12.2 - 43.1 hours.Yeast (c.Albicans) with an inoculum (cfu/bottle) of <=100 time to detection of 17.4-62.4 hours and with an inoculum of [?]10 (cfu/bottle) time to detection 20.5 -70.4 hours.Root cause on 26sep18, a cross functional team (cft) comprised of global customer service, quality assurance, industrialization and research and development microbiology, met to brainstorm and determine root cause for the false negative results.The information in the complaint and the graphs provided by the customer were reviewed and discussed, as well as the information provided in the ifu and the results of the md review and qc testing, and complaint trending.The customer did not provide information regarding the preparation of the bioballs and which organisms or if all three organisms (e.Coli, c.Albicans, c.Sporogenes) were inoculated into the bact/alert® pf bottles.The customer did not subculture the bottles.The customer inoculated bact/alert ® iast and bact/alert® inst bottles with 30 cfu of the same lot of bioballs and bottles turned positive but did not state they inoculated the same bioball suspension into bact/alert® pf and bact/alert ® iast/inst bottles at the same time.Clostridium sporogenes is a strict anaerobe and would not grow in the bact/alert ® pf bottle.E.Coli should grow in the bact/alert® pf.The bact/alert® pf lot 1049786 bottles were tested with c.Albicans, e.Coli and nine other organisms.Growth performance met specification for all organisms tested on each filling lot for both bottle types.A review of the complaint trending data found no other false negative complaints for escherichia coli, candida albicans, clostridium sporogenes in bact/alert® pf bottles during the query timeframe.The ifu for bact/alert® pf bottles did not provide performance characteristics for c.Sporogenes.Without detailed information regarding the procedure used by the customer the root cause could not be determined.The most likely root cause is due to over dilution and using the incorrect bottles.Visual inspection was not performed on retained bottle samples since the complaint was not about visual aspects of the product.No trend was identified as there were no other false negative complaints for escherichia coli, candida albicans, clostridium sporogenes in bact/alert® pf bottles during the query timeframe.The customer did not provide detailed information regarding the procedure used therefore the root cause could not be determined.

• Brand Name: BACT/ALERT® SN CULTURE BOTTLE
• Common Device Name: BACT/ALERT® SN CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 7763470
• Report Number: 3002769706-2018-00135
• Device Sequence Number: 1860817
• Product Code: MDB
• UDI-Device Identifier: 03573026055851
• UDI-Public: 03573026055851
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K021123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2018
• Device Catalogue Number: 259794
• Device Lot Number: 1049787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1