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 Problems Fever (1858); Phlebitis (2004); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Event Description

Summary: hospital (b)(6) 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, the patient was continued on cloxacillin and daptomycin treatment for an unknown period of time.The patient ultimately expired, and the customer believes that it is possible that the biofire result contributed to the patient's death.Biofire has requested further information from the customer and is currently investigating this event.No remedial action, corrective action, preventive action, or field safety corrective action (fsca) has been deemed necessary at this time.

Manufacturer Narrative

Investigation: the patient was a 77-year-old male who presented with sign and symptoms of "phlebys", respiratory failure, and fever and was admitted to the hospital due to decompensated heart failure.On an unknown date, the patient was placed on empiric therapy of cloxacillin (500/6h) and daptomycin (500/24h).On (b)(6) 2023, a blood sample was collected from the patient and cultured.On an unknown date, the patient's blood culture sample was tested on the biofire bcid2 panel.The customer reported that the biofire bcid2 panel reported s.Aureus as detected but did not detect meca/c.On an unknown date(s), additional testing was performed.It is unknown if the same sample was used.The testing is as follows gram-positive cocci were observed on gram stain.Culture isolated mrsa which was identified by the microscan walkaway plus system.An immunochromatography test for pbp2a was performed using a abbott¿ clearview¿ pbp2a culture colony test and the result was positive.Meca/c was double checked with by lamp with the eazyplex mrsa plus kit (amplex) starting from a dilution of the strain according to protocol due to the biofire bcid2 panel result, the patient's empiric therapy was maintained for an unknown period of time.The customer reported that due to the progression of disease, the patient was switched to ceftaroline and daptomycin.The patient ultimately expired on (b)(6) 2023 and when the customer was asked if the biofire result caused or contributed to the patient's death, the customer stated that somehow the delay of the treatment correction could have had some effect on the patient prognosis, and therefore contributed, with other factors (e.G., low treatment doses, high mortality rate from staph among others), to the outcome of the patient.Biofire has requested the sample from the customer for an in-house investigation.Biofire's investigation into this event is ongoing and further information has been requested from the customer.The full investigation and associated conclusions will be provided in the final report.No remedial action, corrective action, preventive action, or fsca has been deemed necessary at this time.Conclusion: investigation ongoing.

Event Description

Summary: (b)(6) hospital ((b)(6), spain) 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, the patient was continued on cloxacillin and daptomycin treatment for an unknown period of time.The patient ultimately expired, and the customer believes that it is possible that the biofire bcid2 panel result contributed to the patient's death.To reliably determine possible causes of this discrepancy, more information would be needed but the customer did not respond to further requests for information.Based on historical complaint information, the most likely cause of the discrepant mrsa result was sensitivity/specificity differences between biofire bcid2 panel and other identification methods.

Manufacturer Narrative

Investigation: the patient was a 77-year-old male who presented with sign and symptoms of "phlebys", respiratory failure, and fever and was admitted to the hospital due to decompensated heart failure.Biofire made multiple attempts to clarify the meaning of "phlebys" but did not receive clarification.On an unknown date, the patient was placed on empiric therapy of cloxacillin (500/6h) and daptomycin (500/24h).On (b)(6), 2023, a blood sample was collected from the patient and cultured.On an unknown date, the patient's blood culture sample was tested on the biofire bcid2 panel.The customer reported that the biofire bcid2 panel reported s.Aureus as detected but did not detect meca/c.The run file for the biofire bcid2 panel test was not provided.On an unknown date(s), additional testing was performed.It is unknown if the same sample was used.The testing is as follows: gram-positive cocci were observed on gram stain.Culture isolated mrsa which was identified by the microscan walkaway plus system.An immunochromatography test for pbp2a was performed using an abbott¿ clearview¿ pbp2a culture colony test and the result was positive.Meca/c was double checked with by lamp with the eazyplex mrsa plus kit (amplex) starting from a dilution of the strain according to protocol.Due to the biofire bcid2 panel result, the patient's empiric therapy was maintained for an unknown period of time.The customer reported that due to the progression of disease, the patient was switched to ceftaroline and daptomycin.The patient ultimately expired on (b)(6), 2023 and when the customer was asked if the biofire result caused or contributed to the patient's death, the customer stated that the delay of the treatment correction could have had some effect on the patient prognosis somehow, and therefore contributed, along with other factors (e.G., low treatment doses, high mortality rate from staph among others), to the outcome of the patient.Biofire contacted the customer to obtain the strain, and possible remaining sample for an in-house investigation.Biofire also requested further information about the patient and patient care.Despite multiple requests, neither the strain, possible remaining sample, nor additional information were provided by the customer.Quality control (qc) and field data review: as no lot information was provided, specific qc records were unable to be reviewed.However, all product undergoes qc and meets criteria prior to being released.In the last year, field reports of potential false negative detections for meca/c for the biofire bcid2 panel was observed at a rate of <0.001.Field reports of potential false negative detections for mrej for the biofire bcid2 panel was observed at a rate of <0.001.Conclusion: to reliably determine possible causes of this discrepancy, more information would be needed; however, based on historical complaint information, the most likely cause of the discrepant mrsa result was sensitivity/specificity differences between the biofire bcid2 panel and other identification methods.The biofire bcid2 panel is a highly sensitive, qualitative multiplexed nucleic acid-based tests designed to detect multiple bacterial, and yeast nucleic acids directly from blood culture samples.While rare, discrepancies between biofire bcid2 panel and other identification techniques are a part of normal system performance observed in the field.These discrepancies can be caused by differences in chemistries, organism/assay targets, procedures, software analysis, and assay cut-off thresholds.There could have been an mrej type with mismatches to the target region that may impact detection.The junction, or point of insertion of the sccmec cassette, can lead to a variety of mrej types (i-xxi).Table 118.Of the biofire bcid2 panel ifu details which mrej types are predicted by in silico analysis to be detected and not detected by the biofire bcid2 panel.A subset of mrej types xv, xviii, and xix sequences have mismatches to assay primers that may have an impact on detection.A subset of mrej type ix sequences (2/8) have mismatches to the assay primer(s) that may have an impact on detection.Refer to table 118.Results for meca/c and mrej (mrsa) in s.Aureus isolates tested and predicted reactivity for mrej types of the biofire bcid2 panel ifu for more information.Antimicrobial resistance can occur via multiple mechanisms.Culture is required to obtain isolates for antimicrobial susceptibility testing, and biofire bcid2 panel results should be used in conjunction with culture results for the determination of susceptibility or resistance.A not detected result for the antimicrobial resistance gene assays does not indicate antimicrobial susceptibility.Please note, false negative results can be the result of a variety of sources and causes.Biofire bcid2 panel results must be correlated with the clinical history, epidemiological data, and other data available to the clinician evaluating the patient.Subculturing and standard susceptibility testing of isolates are required to determine antimicrobial susceptibility.Based on all available product data, the biofire bcid2 panel is performing within established performance claims.No evidence suggests that remedial action, corrective action, preventive action, or field safety corrective action is deemed necessary.According to the review of the panel-specific risk analysis document, risk mitigations applied to the biofire bcid2 panel have reduced the overall error rate for each hazard to a level equal to or below the maximum allowable error rate and remain acceptable.Clinical performance: according to table 65.Biofire bcid2 panel clinical performance summary, meca/c and mrej (mrsa) of the biofire bcid2 panel ifu, the positive percent agreement of meca/c and mrej (mrsa) was established to be 91.9% (95% ci 82.5-96.5%) and the negative percent agreement was established to be 98.0% (95% ci 92.9-99.4%).Isolates recovered from false negative specimens were identified as mssa by standard of care (soc) phenotypic antimicrobial susceptibility testing (ast) methods.Isolates recovered from the two false positive 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 drive; salt lake city, UT 84108 ; 8017366354
• MDR Report Key: 17563542
• MDR Text Key: 321319847
• Report Number: 3002773840-2023-00002
• Device Sequence Number: 1
• Product Code: PAM
• UDI-Device Identifier: 00815381020338
• UDI-Public: 00815381020338
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 09/14/2023

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 Model Number: RFIT-ASY-0147
• Device Catalogue Number: RFIT-ASY-0147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male