MAUDE Adverse Event Report: BIOMERIEUX INC. BACT/ALERT FA PLUS; BACT/ALERT® FA PLUS

Catalog Number 410851

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer in (b)(6) notified biomérieux of post bottle inoculation contamination for a patient in association with the bact/alert® fa plus blood culture bottles (ref.410851, lot 4054200).Patient: female cancer patient receiving chemotherapy.A result of an oxidase positive gram-negative bacillus was provided to the treating physician.The patient was given preventative treatment and an antibiogram was done.Pcr was performed on the impacted patient bottles; all bottles obtained an identification of advenella kasmirensis.Biomérieux customer service confirmed advenella kasmirensis is an environmental organism.There is adverse patient impact; the patient received preventative treatment based upon an erroneous test result.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in france notified biomérieux of post bottle inoculation contamination associated with the bact/alert® fa plus blood culture bottles (ref.(b)(4), lot 4054200) while testing a sample from a female cancer patient receiving chemotherapy.In response to the customer compliant, biomérieux conducted an internal investigation.Three hundred retained bottles from lot 4054200 were inspected, no cloudy or turbid bottles were found.Biomérieux reviewed the manufacturing batch records, packaging defect log, and final aql inspection results associated with lot 4054200, and found no anomalies during manufacturing that would cause or contribute to bottle contamination.Lot 4054200 met all quality finished goods release criteria.The bact/alert bottles undergo a steam-based autoclave process during manufacturing.All autoclave cycles have an exposure temperature of 121° c.The organism in this complaint would be killed by this autoclave cycle.Review of the bact/alert® fa plus blood culture bottle package insert confirmed there are sufficient instructions to the customer about how to visually inspect the bottle before use and precautions to warning that precautions must be taken to prevent contamination of the patient sample during both venipuncture and inoculation into the culture bottle.The root cause of the contamination result obtained by the customer could not be determined.The most likely root cause is that the contaminant entered the bottle at the time the bottle was inoculated with the sample (from the environment or other materials used in the blood culture collection).The instrument times to detection (ttd) support this root cause.Refer to section h10.

• Brand Name: BACT/ALERT FA PLUS
• Type of Device: BACT/ALERT® FA PLUS
• Manufacturer (Section D): BIOMERIEUX INC.; 100 rodolphe street; durham NC 27712
• MDR Report Key: 9861374
• MDR Text Key: 186598746
• Report Number: 3002769706-2020-00003
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026357900
• UDI-Public: 03573026357900
• Combination Product (y/n): N
• PMA/PMN Number: K121461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Catalogue Number: 410851
• Device Lot Number: 4054200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1