MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ CHECK-POINTS (CPO); MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT

Catalog Number	445262
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device types: poc.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 max¿ cpo, a false negative vim/imp patient result was obtained.Culture was performed and result was vim/imp positive.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for suspected false negative results when using bd max¿ cpo (ref.445262) kit lot 5021084 was performed by the review of manufacturing records, retain material testing, review of customer¿s data and by the complaint¿s history review.The review of quality control records of bd max¿ cpo lot 5021084 revealed no anomalies that could explain the customer¿s negative results.The retain material of bd max¿ cpo from lot 5021084 was visually inspected and tested.The results were as expected.Customer complained about an amplification curve in the vic channel (vim/imp target) that gave vim/imp negative results with the bd max¿ cpo kit lot 5021084, while culture was positive, and immunochromatography yielded vim.Customer provided run files of run 430 from bd max¿ instrument ct3187 for investigation.Manual pcr curve adjudication of the vim/imp negative sample in position b1 revealed a late and low amplification which did not reach the threshold to be considered positive.Internal control amplification revealed no anomaly.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Nevertheless, this issue did not affect internal control amplification.It must be noted that manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Based on the data and information provided, specimen at or near the assay limit of detection (lod) is the most likely cause to explain the customer¿s negative result.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ cpo kit lot 5021084.The root cause was not identified.However, a sample with a concentration beyond the ct values limits of detection of the assay is the most likely cause to explain the customer¿s discrepant results.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.
Event or Problem Description
It was reported that during use of bd max¿ cpo, a false negative vim/imp patient result was obtained.Culture was performed and result was vim/imp positive.There was no report of patient impact.

• Brand Name: BD MAX¿ CHECK-POINTS (CPO)
• Common Device Name: MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT
• 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: 23066930
• Report Number: 3007420875-2025-00158
• Device Sequence Number: 9850341
• Product Code: OOI
• UDI-Device Identifier: 00382904452629
• UDI-Public: (01)00382904452629(17)260101(10)5021084
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K190613
• 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): 12/04/2025

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: 01/01/2026
• Device Catalogue Number: 445262
• Device Lot Number: 5021084
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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