MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM; MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE

Catalog Number	445373
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of bd respiratory viral panel for bd max¿ system, a discrepant patient covid result was obtained.The sample was positive, but then upon repeat it was negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd max¿ respiratory viral panel assay (ref.(b)(4) from lot: 4121704 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about obtaining a covid positive result that repeated as negative when using the bd max¿ respiratory viral panel kit lot: 4121704.A negative result was also obtained on the biofire platform.Review of the manufacturing records of bd max¿ respiratory viral panel assay indicated that lot: 4121704 was manufactured according to specifications and met performance requirements.Customer provided sample runs (b)(4) from instrument ct1490 that were analyzed.Manual pcr curve adjudication was conducted on the samples targeted by the client in run (b)(4); position a8 and run (b)(4); position a3.Sample in run (b)(4); position a8 (first test) shows a late and low but true amplification of the fam channel (covid target).Sample in run (b)(4); position a3 (repeat test) shows flat curves without any amplification.Manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ respiratory viral panel assay lot: 4121704.The root cause was not identified.Based on the data and information provided, specimens at or near the assay limit of detection (lod), or environmental or cross contamination, are the most likely causes to explain the customer¿s positive results.Moreover, limit of detection can vary between different assays which could explain the discrepancies between platforms.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard or trends was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
Event or Problem Description
It was reported that during use of bd respiratory viral panel for bd max¿ system, a discrepant patient covid result was obtained.The sample was positive, but then upon repeat it was negative.There was no report of patient impact.

• Brand Name: BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
• Common Device Name: MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19999612
• Report Number: 3007420875-2024-00065
• Device Sequence Number: 4929396
• Product Code: QOF
• UDI-Device Identifier: 00382904453732
• UDI-Public: (01)00382904453732
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K230956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Other
• Device Expiration Date: 05/13/2025
• Device Catalogue Number: 445373
• Device Lot Number: 4121704
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/19/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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
• Patient Sex: Unknown