MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER CHEMSTAT PAK; GLUCOSE TEST SYSTEM

Catalog Number	00044345010
Medical Device Problem Codes	High Test Results (2457); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
A discrepancy has been identified in test results generated by the analyzer.Specifically, a clinical user has queried a sample, where the results appear significantly higher compared to corresponding results obtained from the biochemistry department.Upon further review, it has been observed that this is not an isolated incident, multiple samples within the same dataset show consistently elevated values relative to biochemistry results.The issue suggests a potential calibration or performance deviation of the analyzer prior to its withdrawal from service.Analyzer was then out of use.
Additional Manufacturer Narrative
Qc and manufacturing data for the gem premier chemstat (serial #: (b)(6)) were reviewed and no issues or trends were identified.Cartridge data reviewed and concluded the creatinine sensor performance was within specifications on the cartridge (serial number (b)(6) installed on (b)(6) 2025).Suspected interferent substances compromised the intereference rejecting function of the creatinine sensor.No adverse event or patient impact reported.Based on this assessment, no remedial action is required.This incident will be monitored through trending analysis.

• Brand Name: GEM PREMIER CHEMSTAT PAK
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• 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: 22075156
• Report Number: 1217183-2025-00031
• Device Sequence Number: 12937349
• Product Code: CGA
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250210(17)250629(10)250210C
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223090
• 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): 07/30/2025

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 Expiration Date: 06/29/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250210C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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