MalfunctionLPS
HOMOCYSTEINE ENZYMATIC ASSAY
Received May 11, 2026 · Event occurred Apr 17, 2026
Report 1823260-2026-01825 · MDR key 25134856
Device
Product problems
- Incorrect Measurement
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8000 C702 MODULE SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE HOMOCYSTEINE ENZYMATIC ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS A DATA FLAG. THE FIRST REPEAT RESULT FROM AN AUTOMATIC RERUN WAS 0 UMOL/L. THE SECOND REPEAT RESULT FROM AN MANUAL RERUN WAS 0 UMOL/L. THE WARD QUESTIONED THE RESULT, PROMPTING A RERUN. THE THIRD REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:2 DILUTION WAS 111 UMOL/L.