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	04/28/2026
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2026, the customer reported receiving incalculable results on a gem 5000 analyzer and expressed concern that it was unclear whether the reported result was due to failed iqm2 quality checks or analyte values falling outside the analyzer's reportable range.The customer stated that this lack of clarity could impact clinical interpretation and decision-making.Due to uncertainty regarding the meaning of the result, the sample was repeated on a second analyzer, which reportedly produced similar findings.The customer requested clarification regarding the analyzer's reporting logic, specifically when results are displayed with less-than or greater-than reportable range indicators ("<" or ">") versus being reported as "incalculable." to further assess the patient, the customer performed a finger-stick glucose test, which reportedly indicated a glucose value below the reportable range.Based on this result, clinical intervention was initiated.Approximately 20 minutes later, a repeat blood gas sample was analyzed.The customer reported that the patient subsequently expired.The customer expressed concern that the patient's extremely low glucose concentration may have been reported as "incalculable" rather than identified as a critically low result.The customer further stated that only after obtaining the finger-stick glucose result and repeat blood gas analysis did they consider that the patient's clinical condition and/or sample quality may have contributed to the reported analyzer results.
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: 50898442
• Report Number: 1217183-2026-00030
• Device Sequence Number: 10712294
• Product Code: CHL
• UDI-Device Identifier: 08426950807759
• UDI-Public: (01)08426950807759(11)260226(17)260814(10)260226Q
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 09/25/2026

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 Expiration Date: 08/14/2026
• Device Catalogue Number: 00055430010
• Device Lot Number: 260226Q
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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