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

Catalog Number 443419

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Event Description

Report 3 of 3.It was reported that while using bd max¿ staphsr, there were 1 false negative of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "accession number: 100551283801.In 3 independent patient samples, it was found during internal laboratory confirmation of mrsa strains already detected in culture that the bd max staph sr kit reliably detects staphylococcus aureus (nuc gene channel 530/565) and the meca & mecc gene (resistance meca&mecc gene channel 585/630), but the 11 mrej types cassette (11 mrej types channel 475/520) remains negative and the device therefore assesses the detection of mrsa as negative.This is possible in principle due to genetic variability, but there is currently an unusual accumulation of these cases in our laboratory.No false negative results were transmitted and no findings had to be corrected.".

Manufacturer Narrative

D,2a.Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.D.2b.Medical device type: ooi.E.1.Initial reporter prefix: (b)(6) dr.H.6.Investigation summary: the complaint investigation for discrepant results when using the kit bd max¿ staphsr (ref.443419) lot 2270650 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and verification of complaints history.Review of the manufacturing records of bd max staphsr indicated that lot 2270650 was manufactured according to specifications and met performance requirements.The retain material of bd max staphsr from lot 2270650 was tested and the results met the specifications.Customer complained about three samples that gave false negative result with the bd max¿ staphsr assay; the meca/mecc as well as the nuc targets were detected but not the mrej target.According to the customer, samples were identified as mrsa.One picture and three run files (1016, 1018 and 1027 from instrument ct0480) were provided for investigation.The picture shows a bd max¿ staphsr kit from lot 2270650, confirming the lot number mentioned by the customer.Manual pcr curve adjudication was performed across the runs provided.Pcr analysis of three samples revealed no amplification in the fam channel (mrej target) and strong amplification in the vic channel (sa target) as well as in the rox channel (meca/c target).To be detected as mrsa positive with the bd max¿ staphsr assay, a sample must be positive for both the mrej and the meca/c targets.As mentioned in the package insert p0207, the bd max¿ staphsr assay is designed to detect mrej genotypes i, ii, iii, iv, v, vi, vii, ix, xiii, xiv, and xxi which represent most of mrsa strains harboring meca and mecc genes (belonging to different sccmec/mrej types) accounting for more than 98% of worldwide strains tested by bd to date.The investigation suggests that the customer strain may correspond to a mrej type undetected by the bd max¿ staphsr assay.Without analysis of the customer strain, bd was unable to confirm the customer issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max staphsr assay from lot 2270650.The root cause was not identified.Bd acknowledge the customer issue but cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• Brand Name: BD MAX¿ STAPHSR
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17757756
• MDR Text Key: 323907566
• Report Number: 3007420875-2023-00085
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434199
• UDI-Public: 00382904434199
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/11/2024
• Device Catalogue Number: 443419
• Device Lot Number: 2270650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1