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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device types: qqx.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
Report 4 of 5: it was reported that during use of the bd respiratory viral panel for bd max¿ system, a flu a false positive patient result was obtained.Samples were repeated on cepheid genexpert and were negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary there is an indication of a bd pcr cartridges (ref.(b)(4) issue for the lot used by the customer based on the analysis of the complaints received for unusual curves presenting an upward drift in the cy5 channel when using the bd pcr cartridges with the bd max rvp assay.The root cause for the cy5 signal drift issue associated with the bd pcr cartridges lot was identified during corrective and preventive action investigation.A change in the adhesive supplier by bd¿s pcr cartridge label suppliers was identified as the root cause for the observed issue.Actions were taken both internally at bd and externally with our suppliers to prevent the recurrence of this product issue.Bd confirms the complaint based on the investigation that was performed.Bd quality will continue to monitor for trends.
Event or Problem Description
Report 4 of 5: it was reported that during use of the bd respiratory viral panel for bd max¿ system, a flu a false positive patient result was obtained.Samples were repeated on cepheid genexpert and were 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20533212
• Report Number: 3007420875-2024-00104
• Device Sequence Number: 12833227
• Product Code: QOF
• UDI-Device Identifier: 00382904453732
• UDI-Public: (01)00382904453732(11)240712(17)250708(10)4194316
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/31/2025

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: 07/08/2025
• Device Catalogue Number: 445373
• Device Lot Number: 4194316
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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