MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER CHEMSTAT PAK; ENZYMATIC METHOD, CREATININE

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	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported discrepant creatinine results on the gem premier chemstat pak (cartridge) in comparison to results from the lab.Customer reviewed the corrective action report and noticed incalculable interference was detected 4 times and was corrected for creatinine on the same day as the discrepant results.It was reported that there was no patient impact or adverse event.
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Customer reported discrepant creatinine results on the gem premier chemstat pak (cartridge) in comparison to results from the lab.Data review confirmed the following: - creatinine sensor passed chemstat cvp4, chemstat cvp3, chemstat cvp1, and chemstat cvp2.- creatinine sensor experienced a sensor drift during sample # 77 and 81.- excessive creatine interference for creatinine error code 4030 for sample #81, and results were incalculable.Review of gem cartridge data showed creatinine sensor performance was within specifications on this pak s/n (b)(6); elevated samples identified as sid# (b)(6).Noticed @ sid#(b)(6) creatinine & creatine results both jumped excessively high and the subsequent samples were also elevated.Suspected interferent substance compromised interference rejecting function.Creatinine & creatine sensors both recovered too normal.This was confirmed both by customer statement and sample results reviewed.Customer noted there was no patient impact or adverse events reported for any of the patients involved.

• Brand Name: GEM PREMIER CHEMSTAT PAK
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 21752210
• Report Number: 1217183-2025-00025
• Device Sequence Number: 13302511
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250621(17)250203(10)250203A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 07/11/2025

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: 06/21/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250203A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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