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

Catalog Number	445262
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
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 the bd pcr cartridge on the bd max instrument, an unspecified number of false positive check point cpo patient results were obtained.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields were updated because investigation found that the initial mdr was filed against incorrect product: b5: description of event: report 1 of 2: it was reported that during use of bd max¿ check-points (cpo), an unspecified number of false positive patient results were obtained.There was no report of patient impact.D1: medical device brand name: bd max¿ cpo.D2a: common device name: multiple-genus respiratory virus nucleic acid ivd, kit, nucleic acid technique.D2b: medical device type: ooi, poc.D4: catalog: 445262.D4: lot: 4082387.D4: exp date: 03/21/2025.Udi#: (b)(4).G4: pma/510(k)#: k190613.Investigation summary: the complaint investigation for discrepant results when using bd max¿ cpo (ref.(b)(4)) kit lots 4082387 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained of four samples with suspected false positive results for the kpc target with bd max¿ cpo kit lots 4082387 (a1, a2 and a3).Customer provided run files (pdf and csv) for run 7080 from bd max¿ instrument mx0057 for investigation.Manual pcr curve adjudication was conducted across samples a1, a2, a3 and a4, revealing step dislocations and atypical curves without sigmoidal shape in every channel, including the fam channel (kpc target), for all samples, reaching the threshold to give positive results for the kpc target.It is unlikely that the step dislocations are due to true amplification and a root cause could not be identified.Manual curve adjudication has limitations; visual examination of pcr curves for aberrant curve geometry is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ cpo (ref.(b)(4)) kit lots 4082387.The root cause was not identified.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 quality will continue to monitor for trends.
Event or Problem Description
Report 1 of 2: it was reported that during use of bd max¿ check-points (cpo), an unspecified number of false positive patient results were obtained.There was no report of patient impact.

• Brand Name: BD MAX¿ CPO
• Common Device Name: MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE
• 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: 21200968
• Report Number: 3007420875-2025-00023
• Device Sequence Number: 7578092
• Product Code: OOI
• UDI-Device Identifier: 00382904452629
• UDI-Public: (01)00382904452629(11)240322(17)250321(10)4082387
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/13/2025

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: 03/21/2025
• Device Catalogue Number: 445262
• Device Lot Number: 4082387
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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