MalfunctionCDT
TRIGLYCERIDES
Received May 18, 2026 · Event occurred Apr 22, 2026
Report 1823260-2026-01933 · MDR key 25200338
Device
Generic name
Triglycerides Gpo Without Free Glycerol
Manufacturer
Roche DiagnosticsCatalog number
05171407190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TRIGLYCERIDES RESULT WITH A PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 9 MG/DL. THE SAME RESULT WAS OBTAINED DURING A REPEAT ON ANOTHER C702 INSTRUMENT. INTERFERENCE IS SUSPECTED IN THE PATIENT SAMPLE DUE TO THE PATIENT'S OMEGA-3 SUPPLEMENT INTAKE.