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

Catalog Number	00055445010
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Following measurement of a sample associated with patient id (b)(6), a sample associated with patient id (b)(6) was subsequently measured.The user facility reported that when the barcode label for patient id (b)(6) was scanned, the system displayed the previously measured patient id (b)(6).The issue was reported to be associated with the gem 5000 system barcode reader/scanner.As a result, measurement data were uploaded to an online record associated with a different patient's sample slot.There was no adverse patient impact associated with this issue.
Additional Manufacturer Narrative
This is an initial report.The investigation is ongoing.A follow-up report will be submitted upon investigation completion.

• Brand Name: GEM Premier 5000 PAK
• 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: 50483267
• Report Number: 1217183-2026-00021
• Device Sequence Number: 10094401
• Product Code: CHL
• UDI-Device Identifier: 08426950807810
• UDI-Public: (01)08426950807810(11)260307(17)260812(10)260309J
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/27/2026

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: 08/12/2026
• Device Catalogue Number: 00055445010
• Device Lot Number: 260309J
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2026
• 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
• Patient Sex: Unknown