LACTATE DEHYDROGENASE ACC. IFCC VER.2
Received Feb 28, 2025 · Event occurred Feb 6, 2025
Report 1823260-2025-00585 · MDR key 21491686
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsCatalog number
08057958190
Lot number
837913
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT'S SERIAL NUMBERS ARE (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. SAMPLE (B)(6) INITIAL RESULT WAS 435 U/L, AND THE REPEAT RESULT WAS 326 U/L. SAMPLE (B)(6) INITIAL RESULT FROM ANOTHER C503 WAS 797 U/L, AND THE REPEAT RESULT WAS 301 U/L.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) PERFORMED AN INSTRUMENT AND HARDWARE CHECK, CHECKED THE WASHING STATION AND NEEDLE CENTERING. NO ISSUES WERE FOUND. THEY SET UP SOME RULES IN THE SYSTEM TO REPEAT SAMPLES WITH HIGH LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS. THE ROOT CAUSE WAS DETERMINED TO BE A SAMPLE-RELATED ISSUE IN THE PRE-ANALYTICAL SAMPLING PROCESS. THE INVESTIGATION IS COMPLETE WITH NO PRODUCT ISSUE FOUND.