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	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report 9 of 9: it was reported that during use of the bd pcr cartridge on bd max instrument, a false positive flu a patient result was obtained.Sample was repeated on max and was flu a negative.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device types: njr.Investigation summary: the complaint investigation for false positive results when using bd pcr cartridges (ref.437519) lot 4185634, 4149768, 4191581 and 4268747 along with bd max exk dna-1 assay (ref.442817) was performed by review of customer¿s data and by the complaint¿s history review.Customer reported suspecting false positive results on eight samples when using their in-house developed tick assay.Customer provided twelve runs and database form bd max instrument ct3345 for investigation.Analysis showed that all samples targeted in the complaint text - run 129; position a9, 131; a5, 135; a10, 149; b3, 152; b4, 160; a1 and a4, and 161; a8 - are showing an amplification curve in the rox channel.The emurwl target (rox channel) curve¿s appearance does not suggest a true positive result.The bd pcr cartridges (ref.437519) lots used by the customers have been identified as potentially depicting unusual curves presenting an upward drift.The root cause for the signal drift issue associated with the bd pcr cartridges lots 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 apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• 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: 21944919
• Report Number: 3007420875-2025-00072
• Device Sequence Number: 15662551
• Product Code: OOI
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(11)240924(17)261014(10)4268747
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/15/2025

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 Catalogue Number: 437519
• Device Lot Number: 4268747
• 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: 04/15/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1004-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown