MAUDE Adverse Event Report: BIOMERIEUX, INC. FA+BLOOD CULTURE BOTTLE; SYSTEM, BLOOD CULTURING

Model Number AR4NBH72

Device Problem False Positive Result (1227)

Patient Problem Bacterial Infection (1735)

Event Date 01/15/2023

Event Type  malfunction  

Event Description

This lot number of blood culture bottle generated a false positive enterobacterial species result on biofire bcid panel in addition to the true positive staphylococcus species.Resulted in unnecessary broad spectrum antibiotic treatment.

• Brand Name: FA+BLOOD CULTURE BOTTLE
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BIOMERIEUX, INC.; durham NC
• MDR Report Key: 16398956
• MDR Text Key: 309904908
• Report Number: MW5115020
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2023

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
• Device Operator: Health Professional
• Device Model Number: AR4NBH72
• Device Lot Number: 0004101310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male