MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER 5000; ELECTRODE MEASUREMENT, BLOOD GASES (PCO2, PO2) AND BLOOD PH

Catalog Number	00024019255
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported flames coming from the tripplite ups (pn 00025002112) used with their gem premier 5000.It was reported that the gem premier 5000 analyzer was on a mobile cart above the ups and was not affected.
Additional Manufacturer Narrative
The customer reported popping sounds were heard and upon arrival to analyzer, flames were seen coming from the tripplite ups.The reported flaming ups was unable to be confirmed as no photograph or cartridge data were submitted.It was reported by the customer that the analyzer is unaffected and operational.Clinical engineer retired and removed the ups from service.It was reported by the customer that there is no user/patient adverse impact.The manufacturing records were not able to be reviewed as the cartridge serial number was not submitted.The service history records were reviewed for the gem premier 5000 (serial #: (b)(6)) which demonstrated that the gem premier 5000 instrument does not have a history of related malfunctions.

• 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
• 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: 21752272
• Report Number: 1217183-2025-00026
• Device Sequence Number: 9822076
• Product Code: CHL
• UDI-Device Identifier: 08426950870227
• UDI-Public: (01)08426950870227(11)210712
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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
• Device Catalogue Number: 00024019255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2021
• 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