LDL-CHOLESTEROL GEN.3
Received Jun 8, 2026 · Event occurred May 20, 2026
Report 1823260-2026-02244 · MDR key 25426792
Device
Generic name
Low Density Lipoprotein Test System
Manufacturer
Roche DiagnosticsCatalog number
07005768190
Product problems
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER REPLACED SEALS AND PROBES. THE MIXER WAS CHECKED. ON A SUBSEQUENT VISIT, THE FIELD SERVICE ENGINEER DID NOT IDENTIFY ANY HARDWARE ISSUES. AN APPLICATION CHECK DID NOT REVEAL ANY GENERAL ISSUES. PRECISION TESTING WAS ACCEPTABLE. CALIBRATION AND CONTROL DATA PROVIDED FOR LDL SHOWED NO ISSUES, SO A GENERAL REAGENT ISSUE IS NOT LIKELY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH LDL-CHOLESTEROL GEN.3 ON A COBAS 8000 C702 MODULE. THE FOLLOWING EXAMPLES WERE PROVIDED: FOR ONE PATIENT SAMPLE THE INITIAL RESULT WAS 4 MG/DL WITH NO INSTRUMENT ALARM. THE REPEAT RESULT WAS 123 MG/DL. FOR A SECOND PATIENT SAMPLE THE INITIAL RESULT WAS -2 MG/DL AND IT WAS ALLEGED THAT NO FLAGS OR ALARMS WERE GENERATED.