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

Catalog Number	00044345010
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that creatinine results from a gem premier chemstat pak (cartridge) were higher than expected.When the same patient samples were tested using an istat system, the creatinine results were within normal range.No patient impact was reported.
Additional Manufacturer Narrative
At the time of the reported complaint, instrumentation laboratory co.Conducted a comprehensive investigation, including a review of the data from the gem premier chemstat pak (cartridge) in question.The review confirmed that the creatinine sensor was operating within specifications, and the root cause of the bias seen between the gem premier chemstat and the comparator device (istat) could not be conclusively determined.As a result, the complaint was closed, and no remedial action was deemed necessary.Important note: instrumentation laboratory co.Recently conducted a self-assessment of its quality management system as part of its ongoing compliance and quality program due diligence.One aspect of this assessment was to perform a retrospective review of product complaints received over the past two years, to assess if any complaints should have been reported to fda following the fda guidance, "medical device reporting for manufacturers".As part of this assessment, we identified a small number of complaints that require retrospective reporting.Please be assured that instrumentation laboratory takes its regulatory responsibilities to the fda and its customers seriously and strives to produce only the highest quality devices.The number of late reported complaints is less than 0.005% of the annual complaint volume received and a capa has been initiated to mitigate future occurrences.Furthermore, the company has and will continue to dedicate the necessary financial and personnel resources (and management oversight) to complete these action plans in a timely manner.

• 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 MA 01730
• Manufacturer Contact: carol marble ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 21587551
• Report Number: 1217183-2025-00007
• Device Sequence Number: 18460458
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)231003(17)240129(10)231003A
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 03/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2024
• Device Catalogue Number: 00044345010
• Device Lot Number: 231003A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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