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

Model Number 443812

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

Common device name: gastrointestinal pathogen panel multiplex nucleic acid-based assay system.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while testing with kit bd max ext enteric bacterial panel false positive results were obtained.There was no report if repeat or confirmatory testing was performed.Patient impact was not reported.

Manufacturer Narrative

H.6.Investigation: the complaint investigation for discrepant results with the bd max extended enteric bacterial panel (xebp) (ref.(b)(4)) lot 0203459 was performed by the review of the manufacturing records, retain material testing, customer¿s data analysis and verification of complaints history.Customer provided data allowing to identify that lot 0290202 of bd max¿ enteric bacterial panel (ebp) (ref.442963) was used with the xebp lot.Review of the manufacturing records of both bd max enteric bacterial panel lot 0290202 and bd max¿ extended enteric bacterial panel lot 0203459 kits indicated that results met the specifications for release and use.Retain material of xebp kit lot 0203459 and ebp kit lot 0290202 were tested in negative and no positive result was obtained for the ebp and the xebp targets.Customer reported false positive results and provided one run file (run #4392) from instrument ct0914 for investigation.In this run, five samples were tested with the bd max¿ extended enteric bacterial panel and one strong campylobacter positive result was obtained in position b1.In addition, four vibrio positive results were obtained in positions b1, b3, b4 and b5.Manual pcr curve adjudication was conducted.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.Analyzes of pcr curves revealed that, for each suspected false positive result, there was an abnormal linear fluorescent signal increase in the vibrio channel (rox, bottom) and those increase did not correspond to true amplifications.The pcr curves pattern showed a step dislocation in the raw pcr signal and generated positive results.It is unlikely the step dislocations are due to true amplification and a root cause could not be identified.There is no indication of an increase in complaints for discrepant results for the bd max¿ extended enteric bacterial panel lot 0203459.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.

Event Description

It was reported while testing with kit bd max ext enteric bacterial panel false positive results were obtained.There was no report if repeat or confirmatory testing was performed.Patient impact was not reported.

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL PANEL
• Type of Device: SEE H.10
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 11238576
• MDR Text Key: 268266625
• Report Number: 3007420875-2021-00001
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: 00382904438128
• Combination Product (y/n): N
• PMA/PMN Number: K170308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: 02/05/2022
• Device Model Number: 443812
• Device Catalogue Number: 443812
• Device Lot Number: 0203459
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1