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

Catalog Number 443985

Device Problem False Negative Result (1225)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.B3.The date received by manufacturer has been used for this field.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 bd max¿ enteric viral panel it never detected sapo.Sapo positive on repeat.The following information was provided by the initial reporter: specimen repeatedly tested with max evp on ct2689 but never detected sapo (only rota and/or adeno).To verify evp result, we tested specimen on another max (ct3078).Local application prepped sample buffer tube using same specimens at site as triplicate.Ct3078 run 32 - accession 1-1, 1-2, 1-3 - from same specimen and triplicated (sapo pos on spec #1 accession 1-1).

Manufacturer Narrative

H.6.Investigation summary: the complaint alleges the bd max instrument had "false positives." customer reported that they are witnessing suspected false positive results for adenovirus while running the enteric viral panel assay.The customer run database was provided to bd service and quality for analysis.This analysis revealed evidence of optical crosstalk between fam and vic optics as well as potential bubbles present in the pcr cartridge thus causing irregularly shaped pcr curves.Bd service acknowledged that the customer has experienced performance issues with this instrument and recommended instrument replacement.A bd field service engineer (fse) was dispatched to the customer site where they performed de-installation of the instrument and sent the instrument back to bd for further investigation.This complaint is confirmed by service and quality.The root cause cannot be determined with the information provided.Sample analysis consisted of customer instrument run data files.Analysis by bd quality revealed evidence of optical crosstalk and bubbles in the pcr cartridge.Review of the device history record for this instrument is not required as this complaint does not allege an early life failure or failure at install of the instrument and the complaint was confirmed through other means.Service history review was performed for the instrument and two additional cases were observed on 30may2023 and 13jun2023 for the complaint failure mode reported.

Event Description

It was reported that while using bd max¿ enteric viral panel it never detected sapo.Sapo positive on repeat.The following information was provided by the initial reporter: specimen repeatedly tested with max evp on ct2689 but never detected sapo (only rota and/or adeno).To verify evp result, we tested specimen on another max (ct3078).Local application prepped sample buffer tube using same specimens at site as triplicate.Ct3078 run 32 - accession 1-1, 1-2, 1-3 - from same specimen and triplicated (sapo pos on spec #1 accession 1-1).

• 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. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547491
• MDR Text Key: 321590809
• Report Number: 3007420875-2023-00075
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904439859
• UDI-Public: 00382904439859
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/25/2023

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: 03/17/2024
• Device Catalogue Number: 443985
• Device Lot Number: 2299659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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