LACTATE DEHYDROGENASE
Received Dec 17, 2025 · Event occurred Nov 28, 2025
Report 1823260-2025-05167 · MDR key 23830470
Device
Generic name
Lactate Dehydrogenase Assay Using Nad/nadh
Manufacturer
Roche DiagnosticsCatalog number
03004732122
Lot number
ASKU
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
A REVIEW OF ANALYZER DATA SHOWED STABLE HARDWARE PERFORMANCE. WATER PRESSURE AND GEAR PUMP PRESSURE WERE WITHIN SPECIFICATIONS. A HARDWARE ISSUE CAN BE EXCLUDED. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING. LDH IS HIGHLY CONCENTRATED WITHIN CELLULAR COMPONENTS. THE PRESENCE OF RESIDUAL PLATELETS OR A GRADIENT OF UNSEPARATED CELLS IN PLASMA CAN LEAD TO FALSELY HIGH RESULTS.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LACTATE DEHYDROGENASE ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN LDH VALUE OF 448 U/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 237 U/L AND 239 U/L.