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	Insufficient Information (4580)
Date of Event	02/18/2025
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 creatinine results from a gem premier chemstat pak (cartridge) were running high based on patients' clinical diagnosis.Results were also correlating high compared to their core lab analyzer.Customer results were reported.No further patient impact has been reported.
Additional Manufacturer Narrative
Customer reported that chemstat crea were higher vs.Lab analyzer and provided correlation study data of total 41 samples involving 3 gem premier chemstat analyzers and four gem pemier chemstat paks (along with regression analysis results using clia ±0.2/10% error limits).The corresponding pak data provided from customer was reviewed and regression analysis per our product claim of ±0.3/15 was conducted.In general, chemstat correlated well vs.The lab analyzer, except for four samples from pak 19810 on ed_pod_3 analyzer (s/n (b)(6).Further investigation found there was a rare extreme high crea sample tested on that pak (sid#(b)(6) @ (b)(6) 2025 12:43), likely compromised the interference rejection layer of the creatinine sensor, which resulted in elevated sample results of sid# (b)(6) tested between (b)(6) 2025 19:00 to 21:41.The sensor was recovered after the iqm process @ 2/15/25 3:00 am.Other than what is described above, no other pak performance issues were identified during the sample testing.We recommend using our product claim (±0.3/15%) to assess the method correlation for crea as the biomatrix variation from sample to sample are different between chemstat and the lab analyzer and they could add additional error to the method bias.The ±0.2/10% is suitable for crea performance assessment in proficiency study.The manufacturing records were reviewed for the gem premier chemstat (cartridge serial #'s (b)(6) which demonstrated that the 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.

• 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: 21621740
• Report Number: 1217183-2025-00020
• Device Sequence Number: 8425738
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250407(17)250130(10)250130A
• 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): 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: 04/07/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250130A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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