MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC VIRAL PANEL; SEE H.10

Catalog Number 443985

Device Problem False Positive Result (1227)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D2a: common device name: gastrointestinal pathogen panel multiplex nucleic acid-based assay system.

Event Description

It was reported that while using bd max¿ enteric viral panel, there was 1 false positive result.This is a report of one occurrence, no report of adverse or injury.The following information was provided by the initial reporter: positive results with unspecific curve progression.It happens again and again that with low fluorescence (100-500) bd max shows a positive result.However, after repeating, this sample is negative.

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 false positive results associated with low fluorescence and non-logarithmic amplification.Customer provided database of instrument ct3018 for investigation.No problematic sample was identified by the customer, however analysis of all the positive samples tested with kit lot 3137907 revealed that only two samples obtained a positive result on the initial test and a negative on the repeat test.Manual pcr curve adjudication of both samples, in the initial test (run 94, position a1 and run 112, position a4), shows late and low but true amplification for either nov or rov targets, respectively, without any anomaly indicative of true low positive results.Low positive samples can occur due to viral titers in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Moreover, no anomaly was observed in the repeat tests (run 96, position a12 and run 113, position a9), both showed no amplification and flat curves.Nevertheless, it must be noted that manual curve adjudication has limitations; visual examination of pcr curves for low signal 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.Bd quality will continue to monitor for trends.

Event Description

It was reported that while using bd max¿ enteric viral panel, there was 1 false positive result.This is a report of one occurrence, no report of adverse or injury.The following information was provided by the initial reporter: positive results with unspecific curve progression.It happens again and again that with low fluorescence (100-500) bd max shows a positive result.However, after repeating, this sample is negative.

• Brand Name: BD MAX¿ ENTERIC VIRAL PANEL
• Type of Device: SEE H.10
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 17990572
• MDR Text Key: 326392112
• Report Number: 3007420875-2023-00099
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

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: 10/08/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/08/2024
• 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