LACTATE DEHYDROGENASE ACC. IFCC VER.2
Received May 7, 2026 · Event occurred Apr 14, 2026
Report 1823260-2026-01791 · MDR key 25115849
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsCatalog number
08057958190
Lot number
989120
Product problems
- High Test Results
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 348 U/L. THE REPEAT RESULT WAS 171 U/L. THE SAMPLE WAS REPEATED AGAIN 5 TIMES AND THE RESULTS WERE 172 U/L, 173 U/L, 212 U/L, 177 U/L, AND 175 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE ALARM TRACE SHOWED NUMEROUS ABNORMAL ASPIRATION, CLOT DETECTED, AND FOAM DETECTED ALARMS. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. NO PRODUCT PROBLEM WAS IDENTIFIED.