MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. GEM PREMIER CHEMSTAT; 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	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the provided data confirmed that creatine results were much higher than normal in all four analyses of this particular patient sample, likely causing the elevated creatinine results reported.In review of instrument data, all the creatinine and creatine sample results of this pak, and the sample results immediately before and after this particular patient sample, concluded the pak was functioning normally.Creatinine sensor performance was within specifications on this pak throughout its usage.Data review also concluded that the analyzer performed as intended.The manufacturing records were reviewed for the gem premier chemstat pak, serial# (b)(6), which passed all manufacturing and qa specifications.A review of the complaint database revealed no trend excursion pertaining to the reported failure mode.There was no patient impact.Based on this assessment, no remedial action is required.
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
An erroneous creatinine result was identified on a sample measured on gem premier chemstat on 8/21/2025.The chemstat creatinine measurement was 316 umol/l, and the lab creatinine result was 166 umol/l.The lab sample was taken within 5 minutes of the chemstat sampling.The iqm corrective action reports showed no issues and didn't flag any interferences.Repeat lab analysis confirmed same result (166 umol/l).Repeat chemstat analysis on 8/28/2025 and returned "incalculable" results; sample flagged as excessive creatine interference.The creatine test has been disabled on the chemstat pending further investigation.No patient impact reported.

• Brand Name: GEM PREMIER CHEMSTAT
• 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: 23063844
• Report Number: 1217183-2025-00044
• Device Sequence Number: 18638820
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250428(17)250916(10)250428A
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 09/16/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250428A
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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