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

Catalog Number	00044345010
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Erroneous high creatinine results (above 5 mg/dl) were identified on three patient samples measured on gem premier chemstat on (b)(6) 2025.No patient impact reported.
Additional Manufacturer Narrative
Data review identified that the gem premier chemstat pak (s/n (b)(6)) was installed on (b)(6) 2025.Data review concluded the gem premier chemstat pak creatinine sensor was performing to claims and within our on-board intelligent quality management (iqm) limits (with acceptable slopes, drifts, cvp recovery, and sensor mv baseline stability.Furthermore, no transient fluidic or electrical issue were identified during sample measurements.The reviewed gem pak data did not indicate any systematic issue in the pak to account for the questioned creatinine results.The manufacturing records were reviewed for the gem premier chemstat (serial #: (b)(6)) which demonstrated that the cartridge was found to pass all manufacturing and qa specifications.A review of the complaint database reveals there is no trend excursion pertaining to the reported failure mode.The service history records were reviewed for the gem premier chemstat (serial #: (b)(6)) which demonstrated that the instrument does not have a history of related malfunctions.The test results submitted by the customer were reviewed.The elevated creatinine samples customer reported were identified as sample id#s in question were analyzed between 30-32 hours cartridge age on (b)(6) 2025.Investigator noted the first sample ((b)(6) 2025 00:10:08); creatinine results jumped to excessive high level and subsequent two samples were also elevated.Suspected interferent substance compromised the interference rejecting function of the creatinine sensor temporarily.However, a root cause of the high creatinine results could not be conclusively determined.There was no patient impact.As a result, the complaint was closed, and no remedial action was deemed necessary.

• Brand Name: GEM PREMIER CHEMSTAT PAK
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 23096528
• Report Number: 1217183-2025-00046
• Device Sequence Number: 15644918
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250721(17)251202(10)250721A
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 12/02/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250721A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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