MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM; MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE

Catalog Number 445373

Device Problem False Positive Result (1227)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

Report 2 of 6: it was reported that during use of the bd respiratory viral panel for bd max¿ system, there were false positives.When repeated using another platform (quidel (flu and rsv) or biorad (covid), the results do not match.(b)(6) positive for flu a, covid, and rsv.Repeated result was only positive for flu a and covid.There was no report of patient impact.

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

Report 2 of 6: it was reported that during use of the bd respiratory viral panel for bd max¿ system, there were false positives.When repeated using another platform (quidel (flu and rsv) or biorad (covid), the results do not match.Run 2113 - a5, positive for flu a, covid, and rsv.Repeated result was only positive for flu a and covid.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ respiratory viral panel assay (ref.(b)(4) from lot 3237371 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about six positive results when using the bd max¿ respiratory viral panel kit lot 3237371 that could not be reproduced using quidel (flu and rsv) or biorad (covid) platforms.Review of the manufacturing records of bd max¿ respiratory viral panel assay indicated that lot 3237371 was manufactured according to specifications and met performance requirements.Customer provided sample runs 2111, 2113 and environmental run 2116 from instrument ct1490 that were analyzed.Manual pcr curve adjudication was conducted across samples identified by the costumer found in run 2111; position a3 and run 2113; position a5, b1, b2, b3 and b5.All gave a low but true amplification.Manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Environmental run (run 2116) showed that 5 samples were tested and one of them gave a cov-2 positive result, suggesting environmental contamination at the customer site.The root cause was not identified.Based on the data and information provided, specimens at or near the assay limit of detection (lod), or environmental or cross contamination, are the most likely causes to explain the customer¿s positive results.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ respiratory viral panel assay lot 3237371.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard or trends was identified.Bd quality will continue to monitor for trends.

• Brand Name: BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM
• Type of Device: MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE
• 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: 18782775
• MDR Text Key: 336313613
• Report Number: 3007420875-2024-00012
• Device Sequence Number: 1
• Product Code: QOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230956
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 445373
• Device Lot Number: 3237371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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