MAUDE Adverse Event Report: APPLIED BIOCODE, INC. BIOCODE® GASTROINTESTINAL PATHOGEN PANEL (GPP)

Model Number GPP FINISHED KIT

Device Problem False Negative Result (1225)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The 3rd party study evaluated the applied biocode gpp with the focus on the four most common bacterial targets and the virus and parasite targets.The study compared retrospective results from gi pathogen detection from applied biocode gpp to testing by bd max enteric bacterial panel.Discordant results were found specific to campylobacter.Upon internal testing by applied biocode, the reported issues with campylobacter was confirmed and isolated to one specific lot, aa-06002.Additional internal testing was conducted by abc with another lot which demonstrated 100% concordance with that lot and confirmed the reported issue was isolated to lot aa-06002.These study results were presented at the american society for microbiology (asm) poster #3866.

Event Description

The initial reported information reported discordant results with campylobacter during a retrospective comparison study with bd and culture.The customer was requesting applied biocode (abc) to provide historical data to support their performance study.Abc requested that the customer provide samples for internal testing.Abc's preliminary testing results showed a very strong positive for campylobacter lot aa-06002, which were not detected (false negarive).Subsequent testing internal testing by abc with additional campylobacter lot was performed and concluded the false negative outcomes were specific to lot aa-06002.The comparison study which included more than 300 samples which were tested of abc's gastrointestinal pathogen panel (gpp) good concordance for most targets.The retrospective review of samples tested by in-use method and by abc post reagent lot change demostrated 100% concordance.Reference: american society of microbiology (asm) poster #3866.

• Brand Name: BIOCODE® GASTROINTESTINAL PATHOGEN PANEL (GPP)
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL
• Manufacturer (Section D): APPLIED BIOCODE, INC.; 12130 mora drive; unit 2; santa fe springs CA 90670
• Manufacturer Contact: mary carvajal ; 12130 mora drive; unit 2; santa fe springs, CA 90670 ; 7143430022
• MDR Report Key: 14825373
• MDR Text Key: 303084498
• Report Number: 3007799234-2022-00003
• Device Sequence Number: 1
• Product Code: PCH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GPP FINISHED KIT
• Device Lot Number: AA-06002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1