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	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.Investigation is in process.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported that between 10pm and 3am on (b)(6), the clinician experienced a number of elevated creatinine results on a gem premier chemstat pak (cartridge) that did not match the lab or patient condition.The results were outside of expectation and therefore flagged immediately as unreliable.No adverse impact to patients.
Additional Manufacturer Narrative
Evaluation confirmed creatinine sensor performance was within specifications.Elevated samples as reported by the customer identified starting @ sid(b)(6) on 21:56 2/27.Potential interference substances in sample id 25 was suspected, which temporarily compromised the interference rejecting layer.Creatinine reports recovered to normal on 2/28 after iqm c process at 2 am confirmed by customer and sample data provided later by the customer.There was no adverse patient impact.The manufacturing records were reviewed for the gem premier chemstat (cartridge serial #: (b)(6)) which demonstrated that the gem premier chemstat 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.No remedial action required.

• 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: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 21701467
• Report Number: 1217183-2025-00023
• Device Sequence Number: 8663819
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250510(17)250106(10)250106B
• 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): 05/02/2025

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: 05/10/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250106B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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