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 07/19/2023

Event Type  malfunction  

Event Description

It was reported that while using bd max¿ mrsa xt, there was a false negative of mrsa.No patient impact reported.The following information was provided by the initial reporter: "results in two cases with mrsa xt kit, meca/mecc was detected, but mrej cassette was not.Result bd max is mrsa negative.All of these specimens tested positive in culture.".

Manufacturer Narrative

D.2b.Medical device type: ooi.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ mrsa xt kit (ref.443461) lot 3081250 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¿ mrsa xt kit indicated that lot 3081250 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ mrsa xt kit from lot 3081250 was tested and the results met the specifications.Customer reported that during a training, two samples gave a mrsa negative result on the bd max¿ instrument but they tested mrsa positive by culture.According to the customer, in both cases, meca/mecc target was detected but not the mrej target.Customer provided one run file (2 from instrument (b)(6) for investigation.Manual pcr curve adjudication was conducted across the twelve samples tested with the bd max¿ mrsa xt kit in run #2.Four samples gave a mrsa negative result, and among them, three (in position a3, a4 and a11) showed no amplification in the fam channel (mrej target) and strong amplification in the rox channel (meca/mecc target).Since both targets must be positive to give a mrsa positive result, it explains why these samples gave a negative result.No anomaly was observed in the curves.Despite multiple attempts made to receive information from the customer, concerning which samples gave a false negative result, no more data was provided.As mentioned in the package insert, 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.It must be noted that sccmec and mrej typing are different typing methods, without any link between them.The investigation suggests that the customer strain may correspond to a mrej type 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 3081250.The root cause was not identified.Bd acknowledge the customer issue but cannot confirm the complaint based on the investigation that was performed.

Event Description

It was reported that while using bd max¿ mrsa xt, there was a false negative of mrsa.No patient impact reported.The following information was provided by the initial reporter: "results in two cases with mrsa xt kit, meca/mecc was detected, but mrej cassette was not.Result bd max is mrsa negative.All of these specimens tested positive in culture.".

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17483642
• MDR Text Key: 321653667
• Report Number: 3007420875-2023-00072
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434618
• UDI-Public: 00382904434618
• 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: 08/22/2023

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
• Device Operator: Other
• Device Catalogue Number: 443461
• Device Lot Number: 3081250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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