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 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.

Event Description

It was reported that bd max¿ staphsr false negative result being reported after further confirmatory testing.The following information was provided by the initial reporter: the customer has an mrsa isolate (spa type t127, clonal complex 1), which despite growth on mrsa chrom agar and further confirmation by labor mvz synlab and the rki, was only identified as mssa in bd max.Is a confirmatory test always performed? yes, culture.In this case the culture was mrsa positive.Were patient samples involved? yes, swab sample.Were erroneous results reported to the clinician? no.Were patients treated based on erroneous results? no.

Event Description

It was reported that bd max¿ staphsr false negative result being reported after further confirmatory testing.The following information was provided by the initial reporter: the customer has an mrsa isolate (spa type t127, clonal complex 1), which despite growth on mrsa chrom agar and further confirmation by labor mvz synlab and the rki, was only identified as mssa in bd max.Is a confirmatory test always performed? yes, culture.In this case the culture was mrsa positive.Were patient samples involved? yes, swab sample.Were erroneous results reported to the clinician? no.Were patients treated based on erroneous results? no.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results when using the kit bd max¿ staphsr (ref (b)(4)) lot 2010376 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 2010376 was tested and the results met the specifications.The sample gave a sa positive and mrsa negative result with the bd max¿ staphsr assay but the isolate grew on mrsa chromagar plate and was later confirmed as mrsa positive by two other laboratories.One pdf from run 4614, performed on ct0489 and results on the isolate performed by 2 other laboratories were provided for investigation.Analysis of run 4614 confirmed that a sa positive result but mrsa negative result was obtained for sample renamed 8732.However, the curves were not visible in the pdf file received and the csv file was not provided, therefore no further analysis could be done with the customer run.According to customer, the isolate from sample 8732 was sent to two laboratories: synlab confirmed the sample as mrsa by resistogram test and robert koch institute identified the sample as mrsa spa type t127.These results confirm that the sample was a true mrsa strain.However, only information concerning spa typing was provided, no other typing information was available such as mrej genotypes.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 suggests that the customer strain may bean undetected by the bd max¿ staphsr assay.It must be noted that spa typing, sccmec and mrej typing are different typing methods, without any link between them.Without analysis of the customer strain, bd was unable to confirm the customer issue.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 bd max staphsr assay lot 2010376.The root cause was not identified.Bd acknowledge the customer issue but cannot confirm the complaint based on the investigation that was performed.

• 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: 15988684
• MDR Text Key: 308271067
• Report Number: 3007420875-2022-00080
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434199
• UDI-Public: 00382904434199
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132822
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/10/2023
• Device Model Number: 443419
• Device Catalogue Number: 443419
• Device Lot Number: 2010376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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