MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 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 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

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 of the kit bd max ext enteric bacterial panel, false positive results on sapovirus and norovirus were obtained.False results were not reported to physician because customer always check positive results/curves.There has been no harm to patients.

Manufacturer Narrative

The following information has been updated with corrected and/or additional information: b.5.Describe event or problem: it was reported that during use of the bd max¿ enteric viral panel, false positive results on sapovirus and adenovirus were obtained.False results were not reported to physician because customer always check positive results/curves.There has been no harm to patients.D.1.Medical device brand name: bd max¿ enteric viral panel d.2.Medical device catalog #: 443985 d.4.Medical device lot #: unknown d.4.Unique identifier (udi) #: (b)(4).G.5.Pma/510(k)#: k220607 h.6.Investigation summary: the complaint investigation for suspected false positive sapovirus (sav) and adenovirus (adv) results when using the bd max¿ enteric viral panel assay (ref.(b)(4) unknown lot number was performed by the analysis of the customer¿s data and verification of complaints history.Customer provided the database of instrument ct1108.Database analysis showed that the rate of positive results varied in time and not linked to specific lots.Despite multiple attempts made to receive information from the customer, no kit lot number nor samples identification about the runs in which the suspected false positive results occurred was provided for the investigation.Only a description in the complaint text was available and database of instrument ct1108 was searched to identify the samples corresponding to the information received (discrepant results of repeated adenovirus with norovirus positive results in initial test and samples discrepant results for the sapovirus target which also tested positive for another target).No samples corresponding to these descriptions could be identified in the database and bd was thus unable to investigate the issue reported by the customer.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 assays.The root cause was not identified.Bd 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.H3 other text : see h.10.

Event Description

It was reported that during use of the bd max¿ enteric viral panel, false positive results on sapovirus and adenovirus were obtained.False results were not reported to physician because customer always check positive results/curves.There has been no harm to patients.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18771023
• MDR Text Key: 336137501
• Report Number: 3007420875-2024-00009
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K220607
• 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: 04/03/2024

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: 443985
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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