GEM PREMIER CHEMSTAT PAK
Received May 22, 2025 · Event occurred Apr 25, 2025
Report 1217183-2025-00031 · MDR key 22075156
Device
Generic name
Glucose Test System
Manufacturer
Instrumentation Laboratory Co.Catalog number
00044345010
Lot number
250210C
Product problems
- High Test Results
- No Apparent Adverse Event
- High Test Results
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A DISCREPANCY HAS BEEN IDENTIFIED IN TEST RESULTS GENERATED BY THE ANALYZER. SPECIFICALLY, A CLINICAL USER HAS QUERIED A SAMPLE, WHERE THE RESULTS APPEAR SIGNIFICANTLY HIGHER COMPARED TO CORRESPONDING RESULTS OBTAINED FROM THE BIOCHEMISTRY DEPARTMENT. UPON FURTHER REVIEW, IT HAS BEEN OBSERVED THAT THIS IS NOT AN ISOLATED INCIDENT, MULTIPLE SAMPLES WITHIN THE SAME DATASET SHOW CONSISTENTLY ELEVATED VALUES RELATIVE TO BIOCHEMISTRY RESULTS. THE ISSUE SUGGESTS A POTENTIAL CALIBRATION OR PERFORMANCE DEVIATION OF THE ANALYZER PRIOR TO ITS WITHDRAWAL FROM SERVICE. ANALYZER WAS THEN OUT OF USE.
Additional Manufacturer Narrative
QC AND MANUFACTURING DATA FOR THE GEM PREMIER CHEMSTAT (SERIAL #: (B)(6)) WERE REVIEWED AND NO ISSUES OR TRENDS WERE IDENTIFIED. CARTRIDGE DATA REVIEWED AND CONCLUDED THE CREATININE SENSOR PERFORMANCE WAS WITHIN SPECIFICATIONS ON THE CARTRIDGE (SERIAL NUMBER (B)(6) INSTALLED ON (B)(6) 2025). SUSPECTED INTERFERENT SUBSTANCES COMPROMISED THE INTEREFERENCE REJECTING FUNCTION OF THE CREATININE SENSOR. NO ADVERSE EVENT OR PATIENT IMPACT REPORTED. BASED ON THIS ASSESSMENT, NO REMEDIAL ACTION IS REQUIRED. THIS INCIDENT WILL BE MONITORED THROUGH TRENDING ANALYSIS.