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

Model Number 443812

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 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 ext enteric bacterial panel a discrepant result was obtained by the laboratory personnel.A subculture was used to confirm this result as a false positive.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

Investigation summary: the complaint investigation for discrepant results when using kit bd max ext enteric bacterial panel (ref.(b)(4)) unknown lot # was performed by the verification of complaints history.Customer complained of a few vibrio positive results with the bd max¿ extended enteric bacterial panel (xebp) assay that were not isolated in culture.Despite multiple attempts made to receive information, no data was provided for the investigation (no kit lot, nor data).Without more detail on this complaint, samples, instrument, or culture method, bd was thus unable to investigate the cause of the customer reported issue.There is no indication of an increase in complaints for discrepant results for the bd max¿ extended enteric bacterial panel product.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).

Event Description

It was reported that while using kit bd max ext enteric bacterial panel a discrepant result was obtained by the laboratory personnel.A subculture was used to confirm this result as a false positive.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL 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: 11363338
• MDR Text Key: 256829382
• Report Number: 3007420875-2021-00004
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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 Model Number: 443812
• Device Catalogue Number: 443812
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1