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	07/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Report 2 of 2: it was reported that during use of bd pcr cartridge on bd max¿ instrument, a false positive patient result was obtained.Test was repeated on max and was negative.There was no report of patient impact.
Event or Problem Description
Report 2 of 2: it was reported that during use of bd pcr cartridge on bd max¿ instrument, a false positive patient result was obtained.Test was repeated on max and was negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary.The complaint investigation for false positive results when using the bd pcr cartridges ref.(b)(4) lots 5056719 and 5076766 was performed by the review of manufacturing records and the complaint¿s history review.Customer complained about observing more noise in their pcr curves.According to customer, this noise led to positive results without pcr curves, requiring repeat testing.Review of the manufacturing records of the bd pcr cartridges indicated that lots 5056719 and 5076766 were manufactured according to specifications.Despite multiple attempts made to receive information, no data was available for the investigation.Without data, bd is unable to identify the cause of the customer issue.There is no indication of a cartridge issue based on the analysis of complaints received for false positive results associated with bd pcr cartridges, lots 5056719 and 5076766.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 was identified.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: 22777940
• Report Number: 3007420875-2025-00123
• Device Sequence Number: 21128390
• Product Code: OOI
• UDI-Device Identifier: 00382904375195
• UDI-Public: (01)00382904375195(11)250225(17)270314(10)5056719
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/16/2025

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: 5056719
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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