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	01/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report 2 of 2: it was reported that during use of bd pcr cartridge on bd max¿ instrument, 8 false positive camplyobacter patient results were obtained.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device types: njr.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
After further evaluation, the previous mfr report # 3007420875-2025-00069 was submitted against wrong product.This report is to be replace by mfr report # 1119779-2025-00338.
Event or Problem Description
Report 2 of 2: it was reported that during use of bd pcr cartridge on bd max¿ instrument, 8 false positive camplyobacter patient results were obtained.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): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21937944
• Report Number: 3007420875-2025-00069
• Device Sequence Number: 20829435
• Product Code: OOI
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(11)240612(17)260704(10)4164798
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 05/01/2025

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: 07/04/2026
• Device Catalogue Number: 437519
• Device Lot Number: 4164798
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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