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

Model Number 443419

Device Problem False Negative Result (1225)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd max¿ staphsr assay on the bd max¿ instrument a false negative result was produced.Confirmatory testing was performed.There was no report of adverse patient impact or results being reported to clinicians.The following information was provided by the initial reporter: "it was reported by the customer that false negative for mrsa result on bd max.Patient result positive for sa but negative for mrsa.Customer alleged false negative for mrsa result on bd max.Patient result positive for sa but negative for mrsa.Sample reran the same.Patient positive for mrsa through different methodology.".

Event Description

It was reported when using the bd max¿ staphsr assay on the bd max¿ instrument a false negative result was produced.Confirmatory testing was performed.There was no report of adverse patient impact or results being reported to clinicians.The following information was provided by the initial reporter: "it was reported by the customer that false negative for mrsa result on bd max.Patient result positive for sa but negative for mrsa.Customer alleged false negative for mrsa result on bd max.Patient result positive for sa but negative for mrsa.Sample reran the same.Patient positive for mrsa through different methodology.".

Manufacturer Narrative

H.6.Investigation: the complaint investigation for discrepant results when using the kit bd max¿ staphsr (ref 443419) lot 1279320 was performed by the review of the manufacturing records, retain material testing and verification of complaints history.Review of the manufacturing records of bd max staphsr indicated that the lot was manufactured according to specifications and met performance requirements.The retain material of bd max staphsr from lot 1279320 was tested and the results met the specifications.Customer reported a discrepant result obtained on a patient sample.The sample gave a sa positive mrsa negative result with the bd max¿ staphsr assay but gave a mrsa positive result with two other methods (id/ast and pbp 2a testing).Two run files (#6391 from instrument ct0591 and #8821 from instrument ct0841) were received for investigation.Manual curves adjudication was performed and showed that, for both runs, there was no amplification of the mrsa target (in the fam channel) but true amplification of the sa target (in the vic channel) as well as true amplification of the meca gene target (in the rox channel) was observed for the customer sample.These results suggest that the sample corresponds to a strain not detected by the bd max¿ staphsr assay.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 meca and mecc harboring mrsa strains (belonging to different sccmec/mrej types) accounting for more than 98% of worldwide strains tested by bd to date.The investigation shows that the customer strain may correspond to a mrej type undetected by the bd max¿ staphsr assay.However, without analysis of the customer strain, bd was unable to confirm.No reagents issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the kit bd max staphsr reagent lot 1279320.The root cause was not identified.However, mrej type strain not detected by the bd max staphsr assay can explain the discrepant customer results.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).Bd quality will continue to monitor for trends.H3 other text : see h.10.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14519587
• MDR Text Key: 300705079
• Report Number: 3007420875-2022-00027
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434199
• UDI-Public: 00382904434199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/16/2023
• Device Model Number: 443419
• Device Catalogue Number: 443419
• Device Lot Number: 1279320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1