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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 positive ndm patient result was obtained.Sample tested positive for the ndm target, although the pcr curve does not show a clear sigmoid shape and the ct is very high.Sample tested negative for the oxa48 and vim/imp targets, while the amplification curves show a clear sigmoid shape and a ct of around 35.Sample was then cultured, which confirmed the positive result for ndm and the negative results for oxa-48 and vim/imp.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using bd max¿ cpo (ref.445262) kit lot 4353394 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Review of the manufacturing records of bd max¿ cpo indicated that lot 4353394 was manufactured according to specifications and met performance requirements.Customer complained about a positive result obtained for the ndm target with the bd max¿ cpo kit lot 4353394.According to the customer, this target did not have a sigmoidal pcr curve, while the oxa48 and the vim/imp targets showed sigmoidal pcr curves but obtained negative results.Culture of the sample confirmed the positive result for the ndm target and negative result for oxa48 and vim/imp targets, and no false result was obtained.Customer provided a picture of their bd max¿ instrument screen for investigation.Limited pcr curves adjudication from the picture revealed late and low, but true amplification that reached the threshold to give a positive result in the cy5 channel (ndm target), and late amplification with ct values too late to be considered positive for oxa48 and vim/imp targets.A positive result for the ndm target and negative results for the oxa48 and vim/imp targets are the expected results in such condition.The specific cutoff values for this assay are proprietary information that cannot be shared with the customer.As stated in the instruction for use, the bd max¿ system provides qualitative results.Any reported ct value or displayed curve should only be used for the purpose of laboratory quality control trending, research, and public health reporting.The ct score/curve shall not be used to overrule or change the reported test results.Instrument and assay shall be used in the manner consistent with applicable labeling.Based on the investigation and information provided, no false result was obtained, there was no issue with the customer results.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 4353394.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 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 max¿ cpo, a false positive ndm patient result was obtained.Sample tested positive for the ndm target, although the pcr curve does not show a clear sigmoid shape and the ct is very high.Sample tested negative for the oxa48 and vim/imp targets, while the amplification curves show a clear sigmoid shape and a ct of around 35.Sample was then cultured, which confirmed the positive result for ndm and the negative results for oxa-48 and vim/imp.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: 22678013
• Report Number: 3007420875-2025-00121
• Device Sequence Number: 18429118
• Product Code: OOI
• UDI-Device Identifier: 00382904452629
• UDI-Public: (01)00382904452629(11)241218(17)260101(10)4353394
• 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): 09/16/2025

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: 4353394
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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