MAUDE Adverse Event Report: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL; SYSTEM, BLOOD CULTURING

Model Number	442192
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter name and address: (b)(6).Investigation summary: customer reported a positive id result for bactec media, while using biofire filmarray® blood culture identification bdic/bcid2 panels.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.Batch has been previously investigated for the reported defect.No additional testing is required at this time.Complaint is unconfirmed based on retention samples and batch history record review results.As per product insert a gram-stained smear from culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.Due to the nature of biological materials in media products and inherent organism variability, the user should be cognizant of potential variable results in the recovery of certain microorganisms.Molecular tests performed on positive blood cultures will detect both viable and non-viable organisms commonly found in culture media.Therefore, molecular test results should be evaluated in conjunction with gram stain results in accordance with standard-of-care practices as well as manufacturer¿s instructions for use.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
Event or Problem Description
It was reported that while using bd bactec¿ plus aerobic/f culture vial, a molecular false positive using a bactec media was obtained by the laboratory personnel.Confirmatory gram testing was performed.There was no indication that results were reported, and there was no patient impact.The following information was provided by the initial reporter: discrepant acinetobact.Result from a positive bactec bc discrepant acinetobacter-baumannii result.Gram stain: gram-positive cocci but no gram-negative bacteria.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL
• Common Device Name: SYSTEM, BLOOD CULTURING
• MDR Report Key: 12729366
• Report Number: 2647876-2021-00235
• Device Sequence Number: 11915601
• Product Code: MDB
• UDI-Device Identifier: 00382904421922
• UDI-Public: 00382904421922
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 442192
• Device Catalogue Number: 442192
• Device Lot Number: 1167675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1