MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SEE H.10

Model Number	443461
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.A device evaluation and/or device history review is anticipated but is not complete.
Event or Problem Description
It was reported that while using bd max¿ mrsa xt one sample falsely classified negative.The following was provided by the initial reporter during use 1 sample was falsely classified by the bd max as a negative mrsa sample.
Event or Problem Description
It was reported that while using bd max¿ mrsa xt one sample falsely classified negative.The following was provided by the initial reporter during use 1 sample was falsely classified by the bd max as a negative mrsa sample.
Additional Manufacturer Narrative
H.6 investigation summary: a retest of the sample gave a positive result for mrsa on the bd max¿ instrument.Both initial and retest of the sample was done using the bd max¿ mrsa xt kit lot 1293474.Complaint history review showed that no other complaint was received on kit lot 1293474.In the last twelve months, complaint history review showed other complaints regarding discrepant or false negative results with the bd max¿ mrsa xt assay.Various potential root causes were identified such as sample containing undetected strain and target at the limit of detection (lod) of the assay.Based on the complaint review, no reagents issue was identified.Also, the kit met the release specifications and qc results were within the trends.Retain material from kit lot 1293474 was visually inspected and tested and all the reactions gave expected positive results.No sample was received for investigation.The database of bd max¿ instrument ct0267 was received.Since runs 3755 and 3761 were identified in the complaint text as containing the suspected false negative sample, only these two runs were extracted and analyzed.In the initial test, the sample in position a08 shows an unusually high fluorescence signal in every channel, compared to the other samples in the same run.The sample was retested in run 3761, in position a03, and obtained a mrsa positive result, without any anomaly in the signal in any channel.Based on the investigation, it is suspected that an issue from unknown origin occurred in the initial test, which impacted the amplification of the mrsa target.Unfortunately, no root cause could be identified but the issue seemed isolated.

• Brand Name: BD MAX¿ MRSA XT
• Common Device Name: SEE H.10
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15246222
• Report Number: 3007420875-2022-00045
• Device Sequence Number: 5807951
• Product Code: NQX
• UDI-Device Identifier: 00382904434618
• UDI-Public: 00382904434618
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 01/09/2023
• Device Model Number: 443461
• Device Catalogue Number: 443461
• Device Lot Number: 1293474
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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