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
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1217183-2022-00003
• Device Sequence Number: 19399080
• Product Code: CHL
• UDI-Device Identifier: 08426950807810
• UDI-Public: 08426950807810
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown