MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS LLC BIOFIRE BCID2 BIOFIRE BLOOD CULTURE PCR; GRAM-POSITIVE BACTERIA AND THEIR RESISTANCE MARKERS

Model Number BCID2

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The biofire bcid2 had detected acinetobacter calcoaceticus-baumannii complex (acbc) on four (4) different bottles as part of a polymicrobial result.In all four (4) instances, the acbc did not grow in confirmatory culture.Bd bactec aerobic plus/f bottle are used in all cases.Fda safety report id # (b)(4).

• Brand Name: BIOFIRE BCID2 BIOFIRE BLOOD CULTURE PCR
• Type of Device: GRAM-POSITIVE BACTERIA AND THEIR RESISTANCE MARKERS
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS LLC; salt lake city UT 84108
• MDR Report Key: 12413336
• MDR Text Key: 270098722
• Report Number: MW5103669
• Device Sequence Number: 3
• Product Code: PAM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/30/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BCID2
• Device Catalogue Number: RFIT-ASY-0147
• Device Lot Number: 1406621
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1