MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) KIT BD MAX ENTERIC VIRAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM

Model Number 443985

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using kit bd max enteric viral panel a false positive result was obtained by the laboratory personnel.A false positive may lead to treatment with a drug that is less effective or ineffective and may be less tolerated.There was no report of patient impact.

Event Description

It was reported that while using kit bd max enteric viral panel a false positive result was obtained by the laboratory personnel.A false positive may lead to treatment with a drug that is less effective or ineffective and may be less tolerated.There was no report of patient impact.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results when using the bd max enteric viral panel assay (ref.(b)(4), lot 0035225 was performed by the review of the 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 0035225 was manufactured according to specifications and met performance requirements.Customer reported discrepant results for one patient sample with the bd max¿ enteric viral panel (evp) kit from lot 0035225 and provided 2 runs from instrument ct0583 (runs: #3456 and 3471).Manual pcr curve adjudication was conducted across discrepant results on runs #3456 and 3471.Manual curve adjudication has limitations; visual examination of pcr curves for low signal and/or aberrant curve geometry is an extremely conservative assessment of the data.The sample was first tested in run 3456, position b05, with fresh stool, and was retested with a new sample preparation in run 3471, position b2.Both times, the sample gave early and strong pcr amplification curves, indicative of a high astrovirus (hastv) viral load.However, when tested in governmental installations, using an in-house pcr and the biofire platform, the sample gave astrovirus negative results.The most probable cause of the customer issue is that this sample contained a high viral load of astrovirus (true positive), but the reference method used was unable to detect it.Bd could not confirm the exact cause for the discrepancy, but based on the pcr curve analysis performed, the customer results appear to be true positive.There is no indication of an increase in complaints for discrepant results for bd max enteric viral panel lot 0035225.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).H3 other text : see h10.

• Brand Name: KIT BD MAX ENTERIC VIRAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 11267448
• MDR Text Key: 256828664
• Report Number: 3007420875-2021-00002
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904439859
• UDI-Public: 00382904439859
• Combination Product (y/n): N
• PMA/PMN Number: K181427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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: 07/18/2021
• Device Model Number: 443985
• Device Catalogue Number: 443985
• Device Lot Number: 0035225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1