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	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report 8 of 12: it was reported that during use of the bd pcr cartridge on bd max instrument, a false positive flu a patient result was obtained.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device types: nqx, njr, ozn g.4.There were multiple pma/510k numbers: k111860, k120138, k130470, investigation summary: the complaint investigation for discrepant results when using the bd pcr cartridges (ref.437519) lot 4204545 with the bd respiratory viral panel for bd max¿ system kit from an unknown kit lot was performed by review of customer¿s data and the complaint¿s history review.Customer reported suspected false positive results for the influenza a (flua) target when using the bd pcr cartridges from lot 4204545 and provided databases from bd max¿ instruments ct1236 and ct2252 for investigation.Customer mentioned run 956 from instrument ct1236 as an example of a suspected false positive flua target result.Analysis of the runs performed with bd pcr cartridges lot 4204545 revealed samples a9/a10 (run 879), a2 (run 891), b2 (run 893), b11 (run 894), a9 (run 900), a4 (run 914) and a9/b12 (run 921) from instrument ct1236, and samples a9 (run 2546), a1 (run 2551) and a1 (run 2579) from instrument ct2252, all gave positive flua target results.Pcr curves adjudication performed on these twelve samples revealed expected true amplification in the cy5 channel (flua target) for all the samples.Samples a9 (run 879) and a2 (run 891) were showing late and low amplification in the cy5 channel (flua target), without any anomaly indicative of true low positive results.Such low positive samples can occur due to viral titers in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Moreover, no fluorescence drift or other issue was observed for these twelve samples, suggesting no issue with bd pcr cartridges.Further analysis revealed that run 956, identified as problematic by the customer, was not performed with bd pcr cartridges from lot 4204545 but with lot 4341137.Analysis showed true amplification in the cy5 channel (flua target) for sample a10, without issue nor fluorescence drift observed.Customer's data analysis showed no fluorescence issue and current complaint is not suspected of being linked to bd cartridge field action.There is no indication of a consumable issue related to the customer issue based on the analysis of the complaints received for discrepant results due to low positive on bd pcr cartridges lot 4204545 using bd respiratory viral panel assay.The root cause was not identified.However, the customer¿s positive results all appear to be true positives, including specimens at or near the assay limit of detection (lod), or environmental or cross contamination.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: 22336761
• Report Number: 3007420875-2025-00106
• Device Sequence Number: 8993944
• Product Code: OOI
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(11)240722(17)260826(10)4204545
• 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
• Report Date (Section B): 06/25/2025

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: 08/26/2026
• Device Catalogue Number: 437519
• Device Lot Number: 4204545
• 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: 06/04/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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