MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC VIRAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Model Number 443985

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Report 1 of 2 it was reported that during use with the bd max¿ enteric viral panel, unexpected results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer noted that 2 different patient samples with accession 908231n and 907955z for ent vir (lot 3005023) visually have same curve but not same norovirus results.Customer noted that it is their good lab practice to review the curve but in this case it is not the same results.Customer noted that the curve for 908231n curve amplified earlier and the curve was ahead for norovirus but still negative compared to 907955z.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results when using the bd max enteric viral panel assay (ref.443985), lot: 3005023 was performed by the review of manufacturing records, retain material testing, analysis of the customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max enteric viral panel indicated that the lot was manufactured according to specifications and met performance requirements.The retain material of bd max enteric viral panel assay from lot: 3005023 was tested and the results were as expected.Customer complained about one positive and one negative result for the norovirus target (nov) with bd max¿ enteric viral panel kit lot: 3005023, while both samples had similar pcr curves.Customer provided only pdf files of runs (b)(4) (initial run) and (b)(4) (repeat test) from bd max¿ instrument ct0438 for investigation, despite multiple requests to obtain the.Csv files or the database.Analysis of run report (b)(4) revealed that sample in position a4 was nov negative, while sample in position a5 was nov positive.These samples correspond to those involved in the customer issue.However, run (b)(4) background curves analysis in the rox channel in top of the cartridge (rov target; 585/630) showed similar amplification at approximately 25 cycles for both samples a4 and a5, with sample a5 having a higher endpoint fluorescence, contrary to customer¿s complaint description, and could explain the different results obtained.Further, communication with the customer revealed that customer used the red and yellow pcr curves in the vic (530/565) and rox (585/630) channels for the analysis.Since the red and yellow curves correspond in fact to sapovirus and astrovirus targets, and not the norovirus target, this explains the customer¿s question.The wrong pcr curves were being reviewed.Nonetheless, analysis of run (b)(4) (repeat test from a new sbt) revealed that both patient samples (b)(4) (position b7) and (b)(4) (position b12) gave a negative result for the nov target and showed no amplification curve, which is not the same result as initially for sample (b)(4).Such discrepancy can occur due to titers in the specimen being at or near the limit of detection of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site, which are the most likely causes to explain the customer¿s discrepant results for patient sample (b)(4).Nevertheless, visual examination of pcr curves for low signal is a conservative assessment of the data, and bd is unable to confirm the exact cause of the discrepancy.Nonetheless, 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 bd max enteric viral panel lot: 3005023.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

Event Description

Report 1 of 2.It was reported that during use with the bd max¿ enteric viral panel, unexpected results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer noted that 2 different patient samples with accession (b)(4) for ent vir (lot: 3005023) visually have same curve but not same norovirus results.Customer noted that it is their good lab practice to review the curve but in this case it is not the same results.Customer noted that the curve for (b)(4) curve amplified earlier and the curve was ahead for norovirus but still negative compared to (b)(4).

• Brand Name: BD MAX¿ ENTERIC VIRAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17323030
• MDR Text Key: 319676571
• Report Number: 3007420875-2023-00063
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904439859
• UDI-Public: 00382904439859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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: 05/18/2024
• Device Model Number: 443985
• Device Catalogue Number: 443985
• Device Lot Number: 3005023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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