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	05/07/2025
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
It was reported that during use of bd pcr cartridge on the bd max¿ instrument, an unspecified number of false positive patient results with unusual pcr curves were obtained.Positive results were retested and were negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for high starting rfu with spc channel and shaky curves in all channels leading to false positive results when using the bd pcr cartridges (ref.(b)(4)) lot 3191345 was performed by the review of manufacturing records and the complaint¿s history review.Review of the manufacturing records of bd pcr cartridges indicated that lot 3191345 was manufactured according to specifications.Customer complained about high starting rfu with spc channel and shaky curves in all channels leading to false positive results in some cases.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 reagent issue based on the analysis of the complaints received for unusual curves on bd pcr cartridges lot 3191345.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.No corrective and preventive action (capa) was initiated at this time since no trend was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
Event or Problem Description
It was reported that during use of bd pcr cartridge on the bd max¿ instrument, an unspecified number of false positive patient results with unusual pcr curves were obtained.Positive results were retested and were negative.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: 22287635
• Report Number: 3007420875-2025-00095
• Device Sequence Number: 18373139
• Product Code: OOI
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(11)230710(17)250730(10)3191345
• 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): 08/01/2025

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: 07/30/2025
• Device Catalogue Number: 437519
• Device Lot Number: 3191345
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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