MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ CDIFF (US); C.DIFFICILE TOXIN GENE AMPLIFICATION ASSAY

Catalog Number	443418
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	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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
Report 1 of 2: it was reported that while testing with bd max¿ cdiff, a positive c.Difficile patient result was obtained.Sample was rerun on same max instrument, and gave a negative result.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: report 2 of 2: it was reported that while testing with bd max¿ cdiff, a positive c.Difficile patient result was obtained.Sample was rerun on same max instrument, and gave a negative result.There was no report of patient impact.Investigation summary the complaint investigation for discrepant results when using the bd max¿ cdiff kit (ref.443418) lots: 3265871 and 3327285 was performed by the review of manufacturing records, review of customer¿s data, and by the complaint¿s history review.Customer complained about obtaining two unexpected positive results presenting an unusual curve geometry that both repeated as negative when using the bd max¿ cdiff kit lots: 3265871 and 3327285.Review of the manufacturing records of bd max¿ cdiff indicated that lots: 3265871 and 3327285 were manufactured according to specifications and met performance requirements.Customer provided database from instruments ct3107 and run files 13014, 13015, 13017, 13019, 13025, 13032 and 13034 that were analyzed.The analysis of the database did not lead to any suspicion regarding the instrument since no increase in the positivity ratio was observed when considering the decks, readers and pump systems.Manual pcr curve adjudication was conducted across all cdiff low positive samples.From the nine samples showing signs of low positivity, eight of them are considered as true low pos samples resulting from true amplification.Sample (b)(6), designated by the customer, gave a jagged curve but is still considered as a low pos due to its general pattern.It must be noted that samples near or at the limit of detection (lod) of the assay may sometimes show unusual amplification patterns and their results may not be reproduced upon retesting.The ninth sample, sample (b)(6) which is the other sample designated by the customer, shows an atypical amplification pattern that is unlikely considered to be the result of true amplification.Manual curve adjudication has limitations; visual examination of pcr curves for low signal and/or aberrant curve geometry is a conservative assessment of the data.The root cause was not identified.However, sample-related inhibition could explain the costumer issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ cdiff kit lot: 3265871, nor 3327285.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 were identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
Event or Problem Description
Report 2 of 2: it was reported that while testing with bd max¿ cdiff, a positive c.Difficile patient result was obtained.Sample was rerun on same max instrument, and gave a negative result.There was no report of patient impact.

• Brand Name: BD MAX¿ CDIFF (US)
• Common Device Name: C.DIFFICILE TOXIN GENE AMPLIFICATION ASSAY
• 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: 19537349
• Report Number: 3007420875-2024-00058
• Device Sequence Number: 8412425
• Product Code: OZN
• UDI-Device Identifier: 00382904434182
• UDI-Public: (01)00382904434182
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 443418
• Device Lot Number: 3327285
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2023
• 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