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	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is an initial report.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Following reports of spurious creatinine results on the gem premier chemstat (serial number (b)(6)) and a full instrument health check by a werfen engineer, werfen application specialists analysed 10 x patient blood samples against a second chemstat and found that the chemstat in question in this case (sn (b)(6)) consistently produced elevated creatinine results.This was a blood sample comparison, no patients have been affected in this particular case.
Additional Manufacturer Narrative
Data submitted by customer was reviewed.Data review showed that the creatinine sensor performance was within specifications (for iqm processes and cvps) for gem premier chemstat s/n (b)(6), gem premier chemstat pak s/n (b)(6).Data review concluded the gem chemstat pak creatinine sensor was found 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 gem premier chemstat s/n (b)(6) instrument was returned for evaluation.Werfen engineers were unable to identify any physical and electrical defects.The device passed all testing with no errors recreated.The manufacturing records were reviewed for gem premier chemstat pak s/n (b)(6) which showed all manufacturing and qa specifications passed.While a specific root cause of the high creatinine results could not be conclusively determined, it is suspected the erroneously high creatinine results was related to patient samples containing unknown interference substance.A review of the complaint database reveals there is no trend excursion pertaining to the reported failure mode.There was no reported adverse 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
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 22161314
• Report Number: 1217183-2025-00034
• Device Sequence Number: 7422051
• Product Code: JFY
• UDI-Device Identifier: 08426951070800
• UDI-Public: (01)08426951070800(11)250719(17)250318(10)250318B
• 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): 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
• Device Expiration Date: 07/19/2025
• Device Catalogue Number: 00044345010
• Device Lot Number: 250318B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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