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

Catalog Number	259790
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 (b)(6) notified biomerieux of issues with growth of clostridium sporogenes atcc 19404 in bact/alert® sn blood culture bottle (reference 259790).The customer reporting having a procedure for accepting these bottles for use in establishing the sterility of stem cells used for transplantation and this procedure follows guidelines set out in the european pharmacopiae guidelines 2011 volume v method 2.6.27.One (1) of the organisms recommended by this method is clostridium sporogenes atcc 19404.When the customer performed the batch acceptance initially on lot no: 1051021 this organism failed to grow when the bottles were inoculated with a concentration of organism at 10-5.A columbia blood agar plate inoculated with the same suspension grew 45 colonies on overnight incubation in anaerobic conditions.A suspension of bacteroides fragilis atcc 25285 at a concentration of 10-6 grew successfully in the bottles.Although not normally used in the procedure the customer used a strain of clostridium perfringens atcc 19401 and this successfully grew in the bottles.The customer attempted the procedure again using a new lot number of bottles (1051203) but again the clostridium sporogenes atcc 19404 failed to grow at a concentration of 10-5 and also at 10-4.Then the customer attempted to use a new strain of organism from a lyophilized culture (reconstituted as per manufactures guidelines) but this too failed to grow.A subculture of the bottles after incubation for seven (7) days failed to recover viable organisms.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was initiated for a customer report of issues with growth of clostridium sporogenes atcc 19404 in bact/alert® sn blood culture bottle (reference 259790).The investigation examined bact/alert® sn lot 1051203 and bact/alert® sn lot 1051021 manufacturing directions, including the quality control release testing documentation, and all results for each lot were within specification.Quality assurance subsequently released the lots for distribution to the field.Historical review of complaint data from 01-nov-2017 through 12-feb-2019 determined this is an isolated incident.There were no other similar complaints associated with bact/alert® sn lot 1051021 or bact/alert® sn lot 1051203.The root cause could not be determined but a study performed by biomérieux involving preparations of microbiologics® kwik-stik¿ clostridium sporogenes atcc® 19404 lyophilized strain product tested with bact/alert® sn lot 1051021 and bact/alert® sn lot 1051203 bottles recovered clostridium sporogenes at both 32.5 °c and 36 °c.The bact/alert® 3d instrument flagged the bottles positive between 18.0 and 35.8 hours the bact/alert® sn product is not intended for use with industry applications and samples.The bact/alert® inst bottle would be the correct bottle to use for stem cell testing.

• Brand Name: BACT/ALERT® SN BLOOD CULTURE BOTTLE
• Common Device Name: BACT/ALERT® SN BLOOD CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 8236192
• Report Number: 3002769706-2019-00002
• Device Sequence Number: 10816831
• Product Code: MDB
• UDI-Device Identifier: 03573026055813
• UDI-Public: 03573026055813
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K021123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 05/01/2019
• Device Catalogue Number: 259790
• Device Lot Number: 1051021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1