MalfunctionLCP
DCA VANTAGE
Received Jun 22, 2026 · Event occurred Jun 2, 2026
Report 3002637618-2026-00074 · MDR key 25574264
Device
Product problems
- Low Test Results
Patient
73 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TECHNIQUE AND MAINTENANCE WERE REVIEWED WITH THE CUSTOMER. SIEMENS HAS REQUESTED RETURN OF REAGENT FOR FURTHER INVESTIGATION. CAUSE OF EVENT IS NOT KNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSELY DEPRESSED HBA1C RESULT COMPARED TO RETESTING ON THE SAME DEVICE AND BY UNKNOWN LAB DEVICE. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.