MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD MAX¿ ENTERIC VIRAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number 443985

Device Problem False Positive Result (1227)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd max¿ enteric viral panel, there was a false positive result.No patient impact.The following information was provided by the initial reporter: "false positive norovirus result during use.".

Manufacturer Narrative

E1:(b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using the bd max¿ enteric viral panel, there was a false positive result.No patient impact.The following information was provided by the initial reporter: "false positive norovirus result during use.".

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results when using the bd max enteric viral panel assay (ref.443985) lot 3137907 was performed by the review of manufacturing records, 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.Customer complained about one suspected false positive result for the norovirus target.According to details in the complaint text, the amplification curve is not sigmoidal and does not correspond to a ct value of 24.9.Customer provided two run files (# 111 and 113) from instrument ct2666 for investigation.Run 111 did not contain any positive result.In run 113, the sample in position a8 was positive for rotavirus, sapovirus and norovirus.However, the customer questioned the norovirus positive result.Manual pcr curve adjudication was performed.The pcr curve pattern for this target showed a step dislocation in the raw pcr signal of the rox top channel (norovirus target, nov), resulting in a nov positive result.It is unlikely that this step dislocation is due to true amplification and a root cause could not be identified.Nevertheless, it must be noted that manual curve adjudication has limitations; visual examination of pcr curves for aberrant curve geometry is a conservative assessment of the data.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 3137907.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

• Brand Name: BD MAX¿ ENTERIC VIRAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• 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: 18095069
• MDR Text Key: 327665458
• Report Number: 3007420875-2023-00103
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181427
• 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: 12/22/2023

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 Catalogue Number: 443985
• Device Lot Number: 3137907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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