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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device type: pch.D.4.Common device name: system, nucleic acid amplification test, dna, antimicrobial resistance marker, direct specimen.D.4.Medical device lot: unknown, d.4.Medical device expiration date: unknown, h.4.Device manufacture date: unknown.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 assay, a discrepant patient result was obtained.There was no report of patient impact.The first test gave a positive result for oxa-48.The second test gave an oxa-48 negative result but curve was visible.The third test gave another oxa-48 positive.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using bd max¿ cpo (ref.(b)(4) ) kit lot 4023878 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer reported obtaining discrepant results for the oxa target when repeating a same sample when using bd max¿ cpo (ref.443979) kit lot 4023878.The sample tested positive two times and negative one time although the customer could observe a visible curve.The sample also tested negative when another testing method was used.Review of the manufacturing records of bd max¿ cpo indicated that lot 4023878 was manufactured according to specifications and met performance requirements.Customer provided runs 1705, 1710 and 1716 from bd max instrument ct0562 for investigation.Manual pcr curve adjudication was conducted across the discrepant samples.The two positive results (run 1705; position a6 and 1716; b5) show real amplification curves, no issue is suspected, and there is no indication of a false result.The sample in run 1710; position b4, which obtained a negative result, shows a late and low amplification curve, suggesting a bacterial load below assay limit of detection for the oxa target.Moreover, analysis revealed that the repeat tests were not done using the same sample tube.Knowing that a new sample was prepared, the repeat test may have contained a lower concentration of target, explaining the negative result.Manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.No information was provided concerning the other method of testing used.Since limit of detection can vary between different assays, this could explain the discrepancies between tests.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ cpo (ref.443979) kits.The root cause was not identified.However, samples at or near the limit of detection of the assay (lod) could explain customer¿s issue.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 or trends was identified bd quality will continue to monitor for trends.
Event or Problem Description
It was reported that during use of bd max¿ cpo assay, a discrepant patient result was obtained.There was no report of patient impact.The first test gave a positive result for oxa-48.The second test gave an oxa-48 negative result but curve was visible.The third test gave another oxa-48 positive.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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20356164
• Report Number: 3007420875-2024-00094
• Device Sequence Number: 12555449
• Product Code: OOI
• UDI-Device Identifier: 00382904452629
• UDI-Public: (01)00382904452629
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/20/2024

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: 445262
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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