CHOLESTEROL GEN.2
Received Jun 17, 2026 · Event occurred May 14, 2026
Report 1823260-2026-02393 · MDR key 25531353
Device
Generic name
Enzymatic Esterase--oxidase, Cholesterol
Manufacturer
Roche DiagnosticsCatalog number
03039773190
Lot number
928807
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 CHOLESTEROL GEN.2 RESULT FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. 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 AFFECTED PATIENT ALSO HAD QUESTIONABLE RESULTS FOR TRIGLYCERIDE, AND LDL-CHOLESTEROL GEN.3. THIS MEDWATCH WILL APPLY TO THE CHOLESTEROL GEN.2 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 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 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). THE INVESTIGATION IS ONGOING.