MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD PCR CARTRIDGE; THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY

Catalog Number	437519
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: there is an indication of a bd pcr cartridges (ref.437519) 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.There is also an indication of a bd pcr cartridges (ref.437519) issue for the lot stated in the customer¿s complaint based on the analysis of the complaints received for cy5.5 channel fluorescence issue and/or unresolved results with the bd max ebp assay.The root cause for the cy5 and cy5.5 channel fluorescence signal issues 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.This mdr is being submitted as part of a retrospective review of records dating april 2023¿2025, under capa 11910483.
Event or Problem Description
It was reported while using bd pcr cartridge, there were an unknown number of false positive results.There was no report of patient impact.

• Brand Name: BD PCR CARTRIDGE
• Common Device Name: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY
• 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: 22948614
• Report Number: 3007420875-2025-00146
• Device Sequence Number: 9515128
• Product Code: OOI
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(11)240522(17)260610(10)4143963
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 05/22/2024
• Device Catalogue Number: 437519
• Device Lot Number: 4143963
• 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: 10/17/2024
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2026
• 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