MAUDE Adverse Event Report: Instrumentation Laboratory Co. GEM Premier 5000; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Catalog Number	00055430010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2026
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2026, the customer reported a delay in obtaining lactate testing results on a gem 5000 analyzer located in the he emergency department.The customer stated that a patient death had occured follwoing a delay in obtaining lactate results, as lactate could not be measured in the er and testing had to be delayed until the patient reached the icu.
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon investigation completion.

• Brand Name: GEM Premier 5000
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): Instrumentation Laboratory Co.; 180 hartwell road; bedford MA 01730 -244
• Manufacturer (Section G): Instrumentation Laboratory Co.; 180 hartwell road; bedford MA 01730 -244
• Manufacturer Contact: keith kelly ; 180 hartwell road; bedford, MA 01730--244
• MDR Report Key: 50236251
• Report Number: 1217183-2026-00016
• Device Sequence Number: 10273384
• Product Code: CHL
• UDI-Device Identifier: 08426950807759
• UDI-Public: (01)08426950807759
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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 Catalogue Number: 00055430010
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown