DCA VANTAGE
Received Mar 28, 2025 · Event occurred Feb 21, 2025
Report 3002637618-2025-00023 · MDR key 21716453
Device
Product problems
- Patient Data Problem
- Patient Data Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE DCA VANTAGE ANALYZER MIXED RESULTS FROM TWO DIFFERENT PATIENT SAMPLES TESTED WITH THE UNIQUE SAMPLE IDENTIFICATION (ID). THE DCA GENERATED RESULTS FROM A SAMPLE PROCESSED ON PATIENT-1, AND COMBINED THE RESULTS FROM A PATIENT-2 SAMPLE USING THE ID OF PATIENT-2. WHILE NO RESULTS WERE DISPLAYED FOR THE PATIENT-1 ID. RESULTS WERE REPORTED TO PHYSICIAN. NO DELAYED OR UNNECESSARY TREATMENT/MEDICAL PROCEDURE.
Additional Manufacturer Narrative
THE CUSTOMER RETURNED THEIR SYSTEM TO SIEMENS FOR PHYSICAL INSPECTION AND INVESTIGATION. AN INVESTIGATION WAS CONDUCTED ON THE RETURNED DEVICE. AS PART OF THE INVESTIGATION, THE DATABASE WAS REVIEWED. NO PATIENT RESULTS WERE DOCUMENTED AS REPORTED. THE ROOT CAUSE IS UNKNOWN. INSTRUMENT IS OPERATING AS INTENDED.