GEM PREMIER CHEMSTAT PAK
Received Nov 7, 2025 · Event occurred Oct 8, 2025
Report 1217183-2025-00048 · MDR key 23500580
Device
Generic name
Glucose Oxidase, Glucose
Manufacturer
Instrumentation Laboratory Co.Catalog number
00044330010
Lot number
250623B
Product problems
- Incorrect Measurement
- Device Ingredient or Reagent Problem
- Incorrect Measurement
- Device Ingredient or Reagent Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
POOR PERFORMANCE FOR CREATININE ON CHEMSTAT ON CHEMSTAT SYSTEM WAS OBSERVED DURING A RECENT EQA DISTRIBUTION (B)(4). IN ADDITION, PATIENT RESULT DISCREPANCIES WERE OBSERVED ON CARTRIDGE DETAILS. THE SAME CARTRIDGE WAS EXHIBITING MULTIPLE "SOLUTION DETECT ERROR DURING SAMPLE" AND REQUIRED REPLACEMENT ON 10/08/2025 DUE TO A "REFERENCE VOLTAGE ERROR". CUSTOMER REPORTED THAT THE NEW CARTRIDGE (BATCH 20908C, SERIAL NUMBER (B)(6) IS PERFORMING MORE IN LINE WITH THEIR CREATININE EXPECTATIONS. NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.
Additional Manufacturer Narrative
THE CARTRIDGE ASSOCIATED WITH THE REPORTED DISCREPANCIES (CARTRIDGE SERIAL NUMBER (B)(6)) WAS INSTALLED ON SEPTEMBER 19, 2025, AND REMOVED ON OCTOBER 8, 2025, AFTER TESTING 186 SAMPLES. PERFORMANCE REVIEW CONFIRMED THE CREATININE SENSOR PERFORMED WITHIN SPECIFICATIONS; HOWEVER, TWO SAMPLES (IDS #16 AND #18) TESTED ON SEPTEMBER 19, 2025, SHOWED ELEVATED POSITIVE BIAS COMPARED TO LABORATORY RESULTS. EXCESSIVE MICRO-CLOT FLAGS WERE ALSO OBSERVED, TRIGGERING MULTIPLE IQM PROCESSES TO CORRECT FLUIDIC ISSUES AND ASSOCIATED SENSOR ERRORS. NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED, BUT THE POTENTIAL CAUSE FOR THE ERRONEOUSLY HIGH CREATININE RESULTS WAS LINKED TO UNKNOWN INTERFERENCE SUBSTANCES IN PATIENT SAMPLES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE GEM CHEMSTAT (CARTRIDGE SERIAL #: (B)(6)) AND CONFIRMED THE GEM CHEMSTAT CARTRIDGE MET ALL MANUFACTURING AND QA SPECIFICATIONS. THE SERVICE HISTORY RECORDS WERE REVIEWED FOR THE GEM PREMIER CHEMSTAT (SERIAL #: (B)(6)) AND CONFIRMED THAT THE INSTRUMENT DOES NOT HAVE A HISTORY OF RELATED MALFUNCTIONS. COMPLAINT DATABASE REVIEW INDICATED NO TREND EXCURSION FOR THIS FAILURE MODE. THIS EVENT IS CONSIDERED FORESEEABLE PER GEM PREMIER CHEMSTAT RISK DOCUMENTATION AND IS DOCUMENTED IN THE GEM PREMIER CHEMSTAT INSTRUCTION FOR USE (IFU). THERE WAS NO PATIENT IMPACT. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.