MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER 4000 PAK; ELECTRODE MEASUREMENT, BLOOD GASES

Catalog Number	00027407504
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the gem premier 4000 pak cartridge was leaking red fluid.
Additional Manufacturer Narrative
Customer reported cartridge leaking red fluid, however the cartridge was not returned, nor were photos provided.The manufacturing records were reviewed for the gem premier 4000 cartridge cartridge (serial # (b)(6): which demonstrated that the gem premier 4000 cartridge was found to pass all manufacturing and quality assurance (qa) specifications.A review of the complaint database revealed no trend excursion pertaining to the reported failure mode.Therefore, no remedial action required.
Event or Problem Description
The customer reported that a gem premier 4000 pak cartridge (cartridge serial number:(b)(6), instrument serial number:(b)(6) was leaking red fluid.Customer used universal precautions to clean leak.There was no operator injury.

• Brand Name: GEM PREMIER 4000 PAK
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD GASES
• 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: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 21267053
• Report Number: 1217183-2025-00001
• Device Sequence Number: 18269020
• Product Code: CHL
• UDI-Device Identifier: 08426950554806
• UDI-Public: (01)08426950554806(11)240924(17)250116(10)240924B
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2025
• Device Catalogue Number: 00027407504
• Device Lot Number: 240924B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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
• Patient Sex: Unknown