MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER 5000

Catalog Number	00024019255
Medical Device Problem Code	Date/Time-Related Software Problem (2582)
Health Effect - Clinical Codes	Abnormal Blood Gases (1034); Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
On august 28, 2025, the manufacturer received a customer complaint reporting time discrepancy in blood gas analysis performed on the gem premier 5000.On (b)(6) 2024, there was a discrepancy of approximately 20 minutes between the actual time and the time displayed on the gem premier 5000.There was no report of any malfunction with the blood gas analyzer at the time of use.
Additional Manufacturer Narrative
Investigation determined that the customer used device with the network time protocol (ntp) disabled.If the ntp is disabled, then it is possible for the device's internal time to become asynchronous with standardized external time systems.There were no identified device malfunctions; nor reports from the customer of erroneous results at the time of use.Based on this assessment, no remedial action is required.

• Brand Name: GEM PREMIER 5000
• Common Device Name: GEM PREMIER 5000
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 23076973
• Report Number: 1217183-2025-00043
• Device Sequence Number: 18571900
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: (01)08426950870227(11)200706
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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 Catalogue Number: 00024019255
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2020
• 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: Death
• Patient Sex: Male