MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

Model Number RFIT-ASY-0147

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

Summary: (b)(6) hospital reported a potential false negative methicillin-resistant staphylococcus aureus (mrsa) result on the biofire blood culture identification 2 (bcid2) panel after testing a patient blood culture sample.Due to the biofire bcid2 panel result, a patient may have received inappropriate treatment for an unknown period of time.The investigation concluded the most likely cause of the false negative result was due to a reagent pouch anomaly.

Manufacturer Narrative

Investigation: the patient was a 54-year-old female who presented with signs and symptoms of asthma and cellulitis.Patient sample was collected on (b)(6) 2023 and inoculated in an aerobic and an anaerobic blood culture bottle.On (b)(6) 2023, a blood culture sample from the aerobic bottle was tested on the biofire bcid2 panel.The biofire bcid2 panel reported staphylococcus aureus and staphylococcus spp.As detected.On (b)(6) 2023, biofire bcid2 panel test was repeated on the same blood culture sample from the aerobic bottle.The biofire bcid2 panel reported meca/c and mrej (mrsa), s.Aureus, and staphylococcus spp.As detected.Another biofire bcid2 panel test was performed, but on a sample from the anaerobic blood culture bottle.The biofire bcid2 panel reported meca/c and mrej (mrsa), s.Aureus, and staphylococcus spp.As detected.All additional testing used the same sample.Gram-positive cocci in clusters were observed on gram stain.Vitek ms identified staphylococcus aureus and vitek ast-gp75 reported oxacillin resistance.The customer reported that due to the biofire bcid2 panel result, the patient's treatment was switched from vancomycin to ancef for an unknown period of time.It is unknown if the patient experienced any negative side effects due to the inappropriate treatment.No patient harm was reported, and the current status of the patient is unknown.Quality control (qc) records for biofire bcid2 panel pouch lot# 2zpy23 (kit lot# 2089223) were reviewed.This pouch lot passed qc criteria and was found within specifications.The filmarray instrument (serial number# (b)(6) was working within designed specifications.Conclusion: upon investigation, the biofire reagent lot is performing within specifications in the field.The investigation concluded the most likely cause of the false negative result was due to a pouch anomaly.Biofire is continuously monitoring the manufacturing process and has controls in place to ensure the product is manufactured to the highest quality.Each biofire reagent lot is qualified prior to product release; this qualification includes a high statistical-confidence sampling to confirm that the kit components released for customer use are conforming.All qc metrics for the pouch lot and instrument were met, and they passed qc.Review of the associated instrument showed the instrument was performing within specification and is not expected to have contributed to the discrepancies observed by the customer.Overall, the meca/c assay and mrej assay (for mrsa detection) has a false negative rate of <0.001 in the field over the last year.These rates are within biofire system specifications.According to table 65.Biofire bcid2 panel clinical performance summary, meca/c and mrej (mrsa) of the biofire bcid2 panel instructions for use (www.Online-ifu.Com/iti0048) the performance claim for the meca/c and mrej (mrsa) compared to soc phenotypic ast methods showed an overall sensitivity of 91.9% (95% ci 82.5-96.5%) and an overall specificity of 98.0% (95% ci 92.9-99.4%).Isolates recovered from the five fn specimens were identified as mssa by soc phenotypic ast methods.Isolates recovered from the two fp specimens were identified as mrsa by soc phenotypic ast methods.

• Brand Name: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
• Type of Device: BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
• Manufacturer (Section D): BIOFIRE DIAGNOSTICS, LLC; 515 colorow dr; salt lake city UT 84108
• Manufacturer (Section G): BIOFIRE DIAGNOSTICS, LLC; 515 colorow dr; salt lake city UT 84108
• Manufacturer Contact: 515 colorow dr; salt lake city, UT 84108 ; 8017366354
• MDR Report Key: 18422438
• MDR Text Key: 331677532
• Report Number: 3002773840-2023-00107
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2023

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: RFIT-ASY-0147
• Device Catalogue Number: RFIT-ASY-0147
• Device Lot Number: 2089223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female