MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD MAX¿ MRSA XT; SEE H.10

Catalog Number 443461

Device Problem False Negative Result (1225)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

D.2 medical device type: nqx, ooi.D.3 common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen e.4 initial reporter phone # (b)(6).H.3.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 that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml that there was false negative.The following information was provided by the initial reporter negative results on the bd max, due to lack of detection of the mec right extremely junction (mrej) region.Culture samples were measured on the bd max, only meca and mecc were detected.Mrsa result by bd max was negative.Then the same samples were measured on the cepheid device (meca/c and scc positive.Result interpreted as positive) the pbp2 test from bacteriology also gave a positive mrsa result.

Event Description

It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml that there was false negative.The following information was provided by the initial reporter negative results on the bd max, due to lack of detection of the mec right extremely junction (mrej) region.Culture samples were measured on the bd max, only meca and mecc were detected.Mrsa result by bd max was negative.Then the same samples were measured on the cepheid device (meca/c and scc positive.Result interpreted as positive) the pbp2 test from bacteriology also gave a positive mrsa result.

Manufacturer Narrative

Annex f code was update from f27 to f26.H.6 investigation summary : the complaint investigation for discrepant results when using the bd max¿ mrsa xt kit (ref.(b)(4)) lot 2278537 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 2278537 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ mrsa xt kit from lot 2278537 was tested and the results met the specifications.Customer reported samples that gave a mrsa negative result with the bd max¿ mrsa xt assay due to a lack of detection of the mrej target.These samples gave positive result with the pbp2 test and mrsa positive result on the cepheid device.Customer provided two run files (26 and 30 from instrument ct3034) for investigation.Manual pcr curve adjudication was conducted across samples a6 in run 26 and a3 in run 30 identified as false negative results by the customer.Analysis of the pcr curves showed a true amplification of the meca/mecc (in rox channel) for these samples, but no amplification of the mrej target (fam channel) was observed.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.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 2278537.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.

• Brand Name: BD MAX¿ MRSA XT
• Type of Device: SEE H.10
• 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: 17438658
• MDR Text Key: 320244116
• Report Number: 1119779-2023-00824
• 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 Expiration Date: 04/08/2024
• Device Catalogue Number: 443461
• Device Lot Number: 2278537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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