MalfunctionLBR
LDL-CHOLESTEROL GEN.3
Received May 11, 2026 · Event occurred Apr 11, 2026
Report 1823260-2026-01846 · MDR key 25142444
Device
Generic name
Low Density Lipoprotein Test System
Manufacturer
Roche DiagnosticsCatalog number
07005768190
Lot number
ASKU
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED A CUSTOMER COMPLAINT REGARDING ALLEGED NON-REPRODUCIBLE LDLC3 ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C 702 MODULE. THE SAMPLE INITIALLY RESULTED IN AN LDL VALUE OF 0.7 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 118.4 MG/DL.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C702 ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.