MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ STAPHSR; SEE H.10

Catalog Number 443419

Device Problem False Negative Result (1225)

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

D.3- common device brand name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.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 max¿ staphsr they acquired false negatives.Event 1 of 2 the following was reported by the initial reporter: 3 samples that channels nuc (530/565 nm) and meca/mecc (585/630 nm) were positive, but mrej (475/520 nm) remained negative.

Manufacturer Narrative

The following were corrected due to the change in lot: d4.Medical device lot #: 3052408 d4.Medical device expiration date: 2024-06-10 h4.Device manufacture date: 2023-02-21 1.Site legal name (fda): geneohm sciences canada, inc.(bd diagnostics) d3: medical device manufacturer: geneohm sciences canada, inc.(bd diagnostics) g1: manufacturing location: geneohm sciences canada, inc.(bd diagnostics) h.6 investigation summary the complaint investigation for discrepant results when using the kit bd max¿ staphsr (ref.(b)(6) lot 3052408 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and verification of complaints history.Review of the manufacturing records of bd max¿ staphsr indicated that lot 3052408 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ staphsr from lot 3052408 was tested and the results met the specifications.Customer complained about three samples that gave false negative result with the bd max¿ staphsr assay.However, these samples were analyzed in a previous reagent complaint investigation.Customer provided another run (#1089) containing one sample not analyzed previously and with the same customer¿s observation.The sample was tested in position a12 and gave a sa positive and mrsa negative result.Manual pcr curve adjudication was performed across this sample.Pcr curves analysis revealed no amplification in the fam channel (mrej target) and strong amplification with similar ct values in vic (sa target) and rox (meca/c target) channels, without any anomaly in the curves.With the bd max¿ staphsr assay, for a sample to be considered mrsa positive, a positive result for both mrej and meca/c targets must be obtained, which was not the case for this sample, explaining the mrsa negative result.Knowing that the customer obtained a mrsa positive result in culture for this sample, such results could be indicative of a sample containing a mrsa strain not detected by the assay.As mentioned in the package insert, 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 mrsa strains harboring meca and mecc genes (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 correspond to a mrej type undetected by the bd max¿ staphsr 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¿ staphsr assay from lot 3052408.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 quality will continue to monitor for trends.

Event Description

It was reported that while using bd max¿ staphsr they acquired false negatives.Event 1 of 2 the following was reported by the initial reporter: 3 samples that channels nuc (530/565 nm) and meca/mecc (585/630 nm) were positive, but mrej (475/520 nm) remained negative.

• 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 MD 21152
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17752952
• MDR Text Key: 323503806
• Report Number: 1119779-2023-00994
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434199
• UDI-Public: 00382904434199
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443419
• Device Lot Number: 3052408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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