MAUDE Adverse Event Report: BIOFIRE DIAGNOSTICS, LLC FILMARRAY® PNEUMONIA PANEL PLUS

Model Number	RFIT-ASY-0143
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: (b)(6) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Current information from the customer indicates that the patient may have been negatively impacted by the biofire result and treatment may have been inappropriately changed.Biofire has requested more information to clarify patient impact.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 or Problem Description
Summary: (b)(6) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Current information from the customer indicates that the patient may have been negatively impacted by the biofire result and treatment may have been inappropriately changed.Biofire has requested more information to clarify patient impact.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.
Additional Manufacturer Narrative
Investigation: lavitec technology jsc (vinh yen city, vietnam) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Current information from the customer indicates that the patient may have been negatively impacted by the biofire result and treatment may have been inappropriately changed.Biofire has requested more information to clarify patient impact.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.Update for follow-up report: biofire is still investigating this event in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.Conclusion: investigation ongoing.
Event or Problem Description
Summary: lavitec technology jsc (vinh yen city, vietnam) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Current information from the customer indicates that the patient may have been negatively impacted by the biofire result and treatment may have been inappropriately changed.Biofire has requested more information to clarify patient impact.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.Update for follow up report: biofire is still investigating this event in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.
Additional Manufacturer Narrative
Investigation: lavitec technology jsc (vinh yen city, vietnam) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Current information from the customer indicates that the patient may have been negatively impacted by the biofire result and treatment may have been inappropriately changed.Biofire has requested more information to clarify patient impact.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.Update for follow-up report: biofire is still investigating this event in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.Please note for annex c and annex d were not correct for the initial and first follow up report.Since the investigation is still ongoing, the correct annex c and annex d is shown in this report.Conclusion: investigation ongoing.
Event or Problem Description
Summary: lavitec technology jsc (vinh yen city, vietnam) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Current information from the customer indicates that the patient may have been negatively impacted by the biofire result and treatment may have been inappropriately changed.Biofire has requested more information to clarify patient impact.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.Update for follow up report: biofire is still investigating this event in order to determine the root cause.The full investigation and associated conclusions will be provided in the final report.Please note for annex c and annex d were not correct for the initial and first follow up report.Since the investigation is still ongoing, the correct annex c and annex d is shown in this report.
Event or Problem Description
Summary: lavitec technology jsc (b)(6), vietnam) reported a potential false negative new delhi metallo-beta-lactamase (ndm) result on the filmarray pneumonia panel plus after testing a patient's sputum sample.Due to the filmarray pneumonia panel plus, the patient's appropriate treatment may have been delayed and patient's condition may have deteriorated.Based on the information provided, the most likely cause of the potential false negative ndm result could not be determined, however it is possible the filmarray torch instrument (serial number#: (b)(6) or the filmarray pneumonia panel plus pouch (lot#: 2y2l23) contributed to the discrepant result.
Additional Manufacturer Narrative
Investigation: the patient was a 76-year-old male in the intensive care unit (icu).The customer reported that the patient presented with sepsis, pneumoniae, and respiratory failure at the time of testing.On (b)(6) 2024, a sputum sample was tested on the filmarray pneumonia panel plus.The pneumonia panel plus reported acinetobacter calcoaceticus-baumannii complex, ctx-m, klebsiella pneumonia, oxa-48-like, pseudomonas aeruginosa, and vim as detected.It is unknown if the same sample was used for additional testing.The customer stated that culture was consistent with filmarray pneumonia panel plus result.Pcr performed on sacace biotechnologies detected ndm and oxa-48-like on pseudomonas aeruginosa colonies.Vitek®2 was performed but it is unknown what was detected as the results were not provided.The customer mentioned no growth was observed in culture twice until two weeks later.On (b)(6) 2024, when asked if the patient was affected by the filmarray pneumonia panel plus result, the customer communicated that the treatment was changed following "filmarray id result (ctx-m), ast following sacace & vitek 2 results." the customer stated "good status" when asked about the patient's current status.On (b)(6) 2024, the customer communicated the following: the customer stated that the patient was treated based on the filmarray pneumonia panel plus results for two weeks.When asked if the patient was harmed or if there were any adverse drug effects related to the treatment, the customer communicated that "the patient's condition is still severe, and the doctor was/is giving colistin + meropenem." when asked if the patient's condition deteriorated, the customer stated "yes, still in icu department now." on (b)(6) 2024, the customer communicated the following: when asked if the change in treatment for the patient was inappropriate, the customer stated, "yes, they changed from meropenem to meropenem + colistin." when asked if the physician took into account the patient's sacace biotechnologies result, the customer stated "firstly, physicians take into account the filmarray result / then physicians changed treatment when they received both results of vitek and sacace." when asked when the patient's colistin + meropenem treatment started, the customer stated "patient started on meropenem.After filmarray and vitek, they changed to meropenem & colistin." based on the customer communication, the patient's appropriate treatment may have been delayed due to the filmarray pneumonia panel plus result.The patient's condition may also have deteriorated due to this delay.The final diagnosis of the patient was sepsis, pneumoniae, and respiratory failure.Quality control (qc) records for pouch lot#: 2y2l23 (kit lot#: 1818823) and filmarray torch instrument (serial number#: (b)(6) were reviewed.The pouch lot and instrument passed qc criteria.The discrepancy reported by the customer was not observed during qc testing.Conclusion: based on the information provided, the most likely cause for the false negative ndm result could not be determined, however it is possible the filmarray torch instrument (serial number#: (b)(6) or the filmarray pneumonia panel plus pouch (lot#: 2y2l23) contributed to the discrepant result.The customer was recommended to send filmarray torch instrument (serial number#: (b)(6) in for service, but the instrument was never received.According to the "interpretation of results" section of the filmarray pneumonia panel plus instruction for use (ifu) (www.Online-ifu.Com/iti0038), for an assay to be called positive, two associated melt curves must be called positive, and both melting temperatures must be similar.Assays that do not meet these criteria are called negative.The ndm assay was observed with a robust signature in 1 out of 2 wells.Due to the positive detection in only 1 out of 2 wells, a not detected result was reported for ndm.It is possible a pouch component could have contributed to the reported erroneous results.The reported discrepancy was observed to have taken place solely on filmarray pneumonia panel plus pouch (lot# 2y2l23) and filmarray torch instrument (serial number#: (b)(6).Therefore, the customer was asked to provide additional run files to further evaluate the performance.Sixty additional run files on filmarray pneumonia panel plus pouch (lot#: 2y2l23) were provided, which had been tested on a different instrument (filmarray 2.0 instrument, serial#: (b)(6).Review of the additional run files showed that the filmarray pneumonia panel plus pouch (lot#: 2y2l23) was performing as expected.However, all additional run files provided were performed several months prior to the reported discrepancy and may not be an accurate representation of the pouch performance at the time of testing.The customer had provided masked images on filmarray torch instrument (serial number#: (b)(6), and a darker region near the lower left quadrant of the array had been observed.The affected quadrant correlated with the single replicate wells that had observed no melt activity.However, it should be noted that other factors could have contributed to the discrepancies.On (b)(6) 2024, it was communicated to the customer that the filmarray torch instrument was suspected and that it would need to be provided for service.It is possible the filmarray torch instrument (serial number#: (b)(6) may have contributed to the discrepancies, however, since the instrument was not provided the failure mode could not be verified.If the filmarray torch instrument (serial number#: (b)(6) is provided in the future, this investigation will be re-opened to further investigate the root cause of the false negatives that had been observed at the customer site.

• Brand Name: FILMARRAY® PNEUMONIA PANEL PLUS
• Common Device Name: FILMARRAY® PNEUMONIA PANEL PLUS
• 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: 20051685
• Report Number: 3002773840-2024-00372
• Device Sequence Number: 12755336
• Product Code: QDS
• UDI-Device Identifier: 00815381020314
• UDI-Public: 00815381020314
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K222601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2024
• Device Model Number: RFIT-ASY-0143
• Device Catalogue Number: RFIT-ASY-0143
• Device Lot Number: 1818823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 07/26/2024; 07/26/2024; 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/18/2024; 10/16/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male