MalfunctionCHH
CHOLESTEROL GEN.2
Received Apr 27, 2026 · Event occurred Apr 6, 2026
Report 1823260-2026-01624 · MDR key 25001605
Device
Generic name
Cholesterol Enzymatic Test
Manufacturer
Roche DiagnosticsCatalog number
04718917190
Lot number
94312701
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ON A COBAS C 111 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A CHOLESTEROL VALUE OF 408.19 MG/DL. THE SAMPLE WAS REPEATED, RESULTING IN CHOLESTEROL VALUES OF 203.71 MG/DL AND 201.57 MG/DL.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C111 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.