LDL-CHOLESTEROL GEN.3
Received Feb 21, 2025 · Event occurred Jan 30, 2025
Report 1823260-2025-00515 · MDR key 21433245
Device
Generic name
Low Density Lipoprotein Test System
Manufacturer
Roche DiagnosticsCatalog number
07005768190
Lot number
833054
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
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM BASED ON THE INFORMATION PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH LDL-CHOLESTEROL GEN.3 (LDLC3) ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 0.4 MG/DL. THE CUSTOMER NOTICED THAT THE INITIAL RESULT WAS <3.8 MG/DL AND IT WAS AUTO-VALIDATED BY THE INFINITY. REPEAT RESULT: 155.6 MG/DL. REPORTEDLY, THE REPEAT RESULT WAS AS EXPECTED.
Additional Manufacturer Narrative
THE C702 MODULE SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. THE FIELD APPLICATION SPECIALIST VISITED THE CUSTOMER'S SITE ON THE DAY OF THE EVENT AND SET A NEW RULE IN INFINITY FOR THE REPETITION OF LOW RESULTS. THE INVESTIGATION IS ONGOING.