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

Catalog Number 251063

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of a false negative result associated with bact/alert® ifn (reference 251063).The customer reported while testing product (a cell growth medium called "mixed media 60", smooth muscle growth) they obtained a false negative result on the bact/alert® 3d instrument for the bact/alert ifa and ifn bottles.The bottles were subcultured due to a cloudy appearance upon unloading them from the instrument.This is an industry customer and there is no patient associated with this event.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated due to an industry customer's report of a false negative result associated with bact/alert® ifn (reference 251063).The investigation examined the bact/alert ifa lot 1051275 and bact/alert ifn lot 1051030 bottle manufacturing directions, including the filling and packaging records, and quality control data for growth promotions.Both lots met all release criteria.Quality assurance subsequently released the two lots for distribution to the field on 19dec2018 and 13jul2018 respectively.A historical review of complaint data determined no adverse trend is present.The investigation is unable to determine the root cause.Based on the information available, possible root causes are: ·the bottle was subcultured to contaminated solid media because the bottle graphs look negative with normal reflectance, and two organisms were present on the subculture plates.The two organisms could be environmental contaminants [microbacterium species and bacillus species].The customer did not state either bottle had any noticeable defects prior to inoculation.Per grau, f.H."nutritional requirements of microbacterium thermosphactum" appl.Environm.Microbio.1979 vol.38 pp.818-820, m.Thermosphactum requires lipids for growth.The organism was detected at the complaining site when the bact/alert bottle was supplemented with fluid d, which contains the lipid tween 80.It is possible there are insufficient lipids in the ifa or ifn bottles or sample to robustly support the growth of m.Thermosphactum.Recommendations to the customer are to follow directions in the bottle instructions for use and to: perform gram stains and subcultures on all bottles that flag positive, or look suspicious to be positive.Repeat culture test on positive sample for confirmation when bottles are suspected to be false negative.Visually check all bottles and culture media for damage, or signs of contamination before use.Perform direct gram stain before inoculating bottle if original sample appears cloudy.Consider addition of supplements for recovery of desired organisms from sample.

• Brand Name: BACT/ALERT® IFN CULTURE BOTTLE
• Type of Device: BACT/ALERT® IFN CULTURE BOTTLE
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe drive; durham NC 27712
• MDR Report Key: 8004209
• MDR Text Key: 126397389
• Report Number: 3002769706-2018-00224
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: K020815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2019
• Device Catalogue Number: 251063
• Device Lot Number: 1051030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1