MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) 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 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd max¿ mrsa xt a sample that was negative came back positive via pcr.The following information was provided by the initial reporter: during verification of mrsa xt test on bd max, we have a sample that was negative in mrsa xt and also in our comparison method easyplex mrsa (amplex).According to culture, it was an mrsa (already known).We sent sample to the partner laboratory for mrsa-pcr: positive there.(b)(4).

Manufacturer Narrative

Event date was update from 7/31/2023 to 7/25/2023.There for b.2 was updated to the correct date.H.6 investigation summary the complaint investigation for discrepant results when using the bd max¿ mrsa xt kit (ref.443461) from unknown lot # was performed by the verification of complaints history.Customer reported that during verification, one sample gave a mrsa negative result with the bd max¿ mrsa xt assay as well as with another method (easyplex® mrsa, amplex) but it gave a mrsa positive result when analyzed by pcr by another laboratory as well as in culture.Despite multiple attempts made to receive information from the customer, no kit lot number nor data was provided for the investigation.Without data, bd is unable to identify the cause of the customer issue.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 products.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.H3 other text : see h.10.

Event Description

It was reported that while using bd max¿ mrsa xt a sample that was negative came back positive via pcr.The following information was provided by the initial reporter: during verification of mrsa xt test on bd max, we have a sample that was negative in mrsa xt and also in our comparison method easyplex mrsa (amplex).According to culture, it was an mrsa (already known).We sent sample to the partner laboratory for mrsa-pcr: positive there.(b)(4).

• Brand Name: BD MAX¿ MRSA XT
• Type of Device: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17591881
• MDR Text Key: 321693567
• Report Number: 1119779-2023-00915
• 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

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443461
• Device Lot Number: UNKNOWN
• 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
• 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