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	Insufficient Information (4580)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the copyildata file from the gem premier chemstat instrument provided by the customer was performed and did not indicate any instrument errors or anomalies.A review of the manufacturing records for the gem premier chemstat cartridge (serial number (b)(6)) confirmed that the cartridge met all established manufacturing and quality assurance specifications, with no nonconformities identified.A review of the complaint database did not reveal any trends or excursions pertaining to the reported failure mode.Accordingly, no remedial action is indicated.Note: this mdr filing is past the 30-day reporting timeframe due to an internal error in complaint assignment to the appropriate risk assessment.
Event or Problem Description
On (b)(6) 2025, a customer reported higher than expected creatinine results from their gem premier chemstat, with some results documented in the patient medical record.Repeat testing performed by the customer on a laboratory chemistry analyzer yielded lower creatinine results.No iqm (intelligent quality management) flags or other errors were reported by the gem premier chemstat instrument.The customer was unable to provide information on patient impact.

• 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: keith kelly ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 23840513
• Report Number: 1217183-2025-00056
• Device Sequence Number: 9445527
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250818(17)251231(10)250818A
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 12/31/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250818A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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