MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ STAPHSR; SEE H10

Catalog Number 443419

Device Problem False Positive Result (1227)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

D2.Additional medical device type: ooi.Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.E1.(b)(6).H3.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 during use with the bd max¿ staphsr, there were an unspecified number of false positive results.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ staphsr kit (ref.(b)(4)) from lot 3291353 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer reported positive results for mrsa when using the bd max¿ staphsr kit lot 3291353 that could not be confirmed by culture.Review of the manufacturing records of bd max staphsr assay indicated that lot 3291353 was manufactured according to specifications and met performance requirements.Runs 8368, 8378, 8379, 8492 and 8498 reports from instrument ct0275 were received for the investigation.For the five samples (run 8368; position a12, 8378; a4, 8379; a8, 8492; a7 and 8498; b12), the analysis revealed that the mrej and nuc gene obtained comparable ct values but the ct of the resistance gene meca/c was later.Mrej, nuc and meca/c sequences are used to identify a sample as s.Aureus positive and methicillin resistant (mrsa); their ct values are expected to be similar.The meca/c gene could have been lost due to a mutation leaving solely the other targeted genes to be amplified.This suggests that those strains were originally resistant to methicillin, but they lost their resistance gene (meca/c) over time through multiple cell divisions (meca/c drop out).In addition, a coinfection is suspected in this case.Indeed, sample containing both mrsa-meca/c dropout (giving the mrej/nuc targets positive result by pcr but mrsa negative in culture) and bacteria other than s.Aureus harboring the meca/c gene could explain the customer discrepant results but the root cause cannot be confirmed.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 3291353.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard or trends was identified.Bd quality will continue to monitor for trends.

Event Description

It was reported that during use with the bd max¿ staphsr, there were an unspecified number of false positive results.There was no report of patient impact.

• Brand Name: BD MAX¿ STAPHSR
• Type of Device: SEE H10
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18924607
• MDR Text Key: 337915707
• Report Number: 3007420875-2024-00024
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434199
• UDI-Public: (01)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: 04/22/2024

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: 443419
• Device Lot Number: 3291353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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