LDL-CHOLESTEROL GEN.3
Received Jun 17, 2026 · Event occurred May 14, 2026
Report 1823260-2026-02392 · MDR key 25531349
Device
Generic name
System, Test, Low Density, Lipoprotein
Manufacturer
Roche DiagnosticsCatalog number
07005717190
Lot number
903945
Product problems
- Incorrect Measurement
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE LDL-CHOLESTEROL GEN.3 RESULT FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL LDL RESULT WAS 154 MG/DL. THE RESULT FROM ANOTHER LABORATORY FROM A NEW SAMPLE ON (B)(6) 2026 USING A COBAS C311 WAS 57 MG/DL. THE RESULT FROM A NEW SAMPLE ON (B)(6) 2026 USING THE COBAS C311 WAS 64 MG/DL. THE AFFECTED PATIENT ALSO HAD QUESTIONABLE RESULTS FOR CHOLESTEROL GEN.2, AND TRIGLYCERIDES. THIS MEDWATCH WILL APPLY TO THE LDL-CHOLESTEROL GEN.3 ASSAY. PLEASE REFER TO: MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE TRIGLYCERIDE ASSAY. MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE CHOLESTEROL GEN.2 ASSAY. THE INITIAL TRIGLYCERIDE RESULT WAS 373 MG/DL. THE RESULT FROM ANOTHER LABORATORY FROM A NEW SAMPLE ON (B)(6) 2026 USING A COBAS C311 WAS 85 MG/DL. THE RESULT FROM A NEW SAMPLE ON (B)(6) 2026 USING THE COBAS C311 WAS 71 MG/DL. THE RESULT FROM THE MAIN LAB ON (B)(6) 2026 USING A COBAS PURE WAS 64 MG/DL THE INITIAL CHOLESTEROL RESULT WAS 248 MG/DL. THE RESULT FROM ANOTHER LABORATORY FROM A NEW SAMPLE ON (B)(6) 2026 USING A COBAS C311 WAS 125 MG/DL. THE RESULT FROM A NEW SAMPLE ON (B)(6) 2026 USING THE COBAS C311 WAS 127 MG/DL. THE RESULT FROM THE MAIN LAB ON (B)(6) 2026 USING A COBAS PURE WAS 124 MG/DL. THE CUSTOMER FOUND THAT THE RESULTS FROM (B)(6) 2026 CORRELATE WITH THE PATIENT'S CLINICAL PICTURE.
Additional Manufacturer Narrative
THE COBAS 4000 C311 STAND ALONE SYSTEM SERIAL NUMBER IS (B)(6).