MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SEE H10

Model Number	443461
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd max¿ mrsa xt the customer received false positive results.Confirmatory testing produced negative results.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "however, about 60% of the samples detected positive with bd max and cepheid mrsa were negative in culture (microbiology)".
Additional Manufacturer Narrative
Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.Medical device expiration date: unknown.Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using bd max¿ mrsa xt the customer received false positive results.Confirmatory testing produced negative results.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "however, about 60% of the samples detected positive with bd max and cepheid mrsa were negative in culture (microbiology)".
Additional Manufacturer Narrative
H.6 investigation summary: the complaint investigation for discrepant results with the bd max¿ mrsa xt kit (ref.(b)(4) unknown lot number was performed by the verification of complaints history.Customer complained about some samples that gave positive results with the bd max¿ mrsa xt assay and another molecular test method but were negative when grown on a selective media in culture.No data was provided for the investigation despite multiple requests made to receive data from customer, thus the investigation was limited.Nonetheless, the fact that the customer obtained the same results with the bd max¿ mrsa xt assay and another molecular test method strongly suggests that the issue is not linked to a reagents failure.Results may be different depending on the testing method used and their respective analytical sensitivity.Moreover, culture methods do not detect non-viable microorganisms, whereas molecular methods do.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results bd max¿ mrsa xt assay.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 plan (capa).Bd quality will continue to monitor for trends.H3 other text : see h.10.

• Brand Name: BD MAX¿ MRSA XT
• Common Device Name: SEE H10
• 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: 15180276
• Report Number: 3007420875-2022-00041
• Device Sequence Number: 17697785
• Product Code: NQX
• UDI-Device Identifier: 00382904434618
• UDI-Public: 00382904434618
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Model Number: 443461
• Device Catalogue Number: 443461
• Device Lot Number: UNKNOWN
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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