MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM 5000 SENSOR AND REAGENT CARTRIDGE; 5K BG/ISE/GL/COOX 450 TEST PAK 31D

Model Number 00055445010

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/23/2022

Event Type  Injury  

Event Description

The manufacturer received a complaint indicating a gem 5000 sensor and reagent cartridge was received with mold on it.The customer reports upon opening the packaging, mold was observed on the exterior of the cartridge case and/or labeling.

Manufacturer Narrative

Instrumentation laboratory conducted an investigation that included a review of the customer-provided photographs demonstrating small amounts of mold on the gem 5000 sensor and reagent cartridge.This event may have occurred due to a possibly broken or incomplete seal of an internal reagent bag.Exposure to environmental molds can cause local skin, eye, or mucosal membrane irritation.Standard laboratory practice is to handle all reagents/cartridges wearing appropriate personal protective equipment, thus limiting exposure to mold or other contaminants.Thus, it is improbable that harm would occur due to the event.No remedial action is required.

• Brand Name: GEM 5000 SENSOR AND REAGENT CARTRIDGE
• Type of Device: 5K BG/ISE/GL/COOX 450 TEST PAK 31D
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 14753662
• MDR Text Key: 294391211
• Report Number: 1217183-2022-00003
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 08426950807810
• UDI-Public: 08426950807810
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K203790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2022
• Device Model Number: 00055445010
• Device Catalogue Number: 00055445010
• Device Lot Number: 220318C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other