MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC

Catalog Number 443461

Device Problem False Negative Result (1225)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone (b)(6) e1.Initial reporter fax there were multiple pma/510k numbers.The information for each additional pma/510k is as follows: g.5.Pma / 510(k)#: ooi h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Report 4 of 4: it was reported that during use with the bd max¿ mrsa xt, there were false negative results.There was no report of patient impact.Runs 186 and 191/sample (b)(6) primary sample material: swab (eswab) swab location: right nose testing eswab bd max mrsa-xt (run 186): mrsa not detected (mrej negative; meca/mecc positive ct 27.8; ic positive) colony testing (from selective plate) fluorotype mrsa (hain bruker): mrsa detected (sccmec positive; meca/mecc positive) colony testing (from selective plate) bd max mrsa-xt (run 191): mrsa not detected (mrej negative; meca/mecc positive ct 23.2; ic negative) mrsa culture: positive (phenotypically mrsa detected) antibiogram: o oxacillin, tetracycline resistant.

Event Description

Report 4 of 4: it was reported that during use with the bd max¿ mrsa xt, there were false negative results.There was no report of patient impact.Runs 186 and 191/sample (b)(4).Primary sample material: swab (eswab).Swab location: right nose.Testing eswab bd max mrsa-xt (run 186): mrsa not detected (mrej negative; meca/mecc positive ct 27.8; ic positive).Colony testing (from selective plate) fluorotype mrsa (hain bruker): mrsa detected (sccmec positive; meca/mecc positive).Colony testing (from selective plate) bd max mrsa-xt (run 191): mrsa not detected (mrej negative; meca/mecc positive ct 23.2; ic negative).Mrsa culture: positive (phenotypically mrsa detected).Antibiogram: o oxacillin, tetracycline resistant.

Manufacturer Narrative

H.6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ mrsa xt kit (ref.443461) from lot: 3265828 was performed by the review of manufacturing records, review of customer¿s data, retain material testing and by the complaint¿s history review.Customer complained about discrepant results when using bd max¿ mrsa xt kit from lot: 3265828 versus culture and hain bruker¿s fluorotype mrsa testing.Review of the manufacturing records of bd max¿ mrsa xt kit indicated that lot: 3265828 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ mrsa xt kit from lot: 3265828 was tested and the results met the specifications.Database of bd max¿ instrument ct3017 was received, for investigation.Runs were analyzed and manual pcr curve adjudication was conducted across the samples identified by the customer (run 186; position a7 and a9, 191; a1, 195; a2 and a3).Analysis revealed that all the affected samples were negative for the mrej target (fam channel) but positive for the meca/c (resistance gene) target (rox channel).No anomaly was observed in the curves and results appear to be true negative results.Based on the culture results reported and hain broker testing results, the customer¿s samples appear to be true mrsa strains.As mentioned in the package insert p0205, the bd max¿ mrsa xt 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.However, it must be noted that sscmec typing and mrej typing are different typing methods, without any link between them.The investigation suggests that the customer strain may have been undetected by the bd max¿ mrsa xt 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¿ mrsa xt assay from lot 3265828.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 since no new hazard or trends was identified.Bd quality will continue to monitor for trends.

• Brand Name: BD MAX¿ MRSA XT
• Type of Device: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC
• 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: 18813418
• MDR Text Key: 336988682
• Report Number: 3007420875-2024-00018
• Device Sequence Number: 1
• Product Code: NQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133605
• 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,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443461
• Device Lot Number: 3265828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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