LACTATE DEHYDROGENASE ACC. IFCC VER.2
Received Dec 8, 2025 · Event occurred Nov 17, 2025
Report 1823260-2025-04987 · MDR key 23742238
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsCatalog number
08057958190
Lot number
89812001
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR LACTATE DEHYDROGENASE ACC. IFCC VER.2 (LDHI2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 653 U/L. THE PHYSICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED ON A DIFFERENT C503 ANALYZER WITH A RESULT OF 207 U/L. THE SAMPLE WAS REPEATED ON THE ORIGINAL C503 ANALYZER WITH A RESULT OF 196 U/L.
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. IMPROPER SAMPLE HANDLING AND/OR CONTAMINATION WITH ERYTHROCYTES LEAD TO ELEVATED LDH RESULTS. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.