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

Model Number 442960

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

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

Event Date 07/13/2021

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.

Event Description

It was reported that while using kit bd max enteric parasite panel 16 false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer problem: epp discrepant results reported by (b)(6): customer reports total 16 samples (on multiple runs) were girardia positive since (b)(6) 2021.All these samples have been repeated 2x and they gave negative results.".

Event Description

It was reported that while using kit bd max enteric parasite panel 16 false positive results were obtained by the laboratory personnel.A repeat test was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer problem: epp discrepant results reported by mas, ek: customer reports total 16 samples (on multiple runs) were girardia positive since (b)(6) 2021.All these samples have been repeated 2x and they gave negative results.".

Manufacturer Narrative

This mdr should be considered cancelled.This was determined to be an instrument issue, not a reagent issue.The instrument malfunction was reported under mfr report number: 1119779-2021-01449.

• Brand Name: KIT BD MAX ENTERIC PARASITE PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• MDR Report Key: 12353493
• MDR Text Key: 267664852
• Report Number: 3007420875-2021-00047
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904429607
• UDI-Public: 00382904429607
• Combination Product (y/n): N
• PMA/PMN Number: K143648
• 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: 09/17/2021

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: 442960
• Device Catalogue Number: 442960
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1