MalfunctionLCP
DCA VANTAGE
Received Apr 8, 2026 · Event occurred Mar 9, 2026
Report 3002637618-2026-00028 · MDR key 24812633
Device
Product problems
- High Test Results
Patient
NA · Unknown
- 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 ELEVATED HBA1C RESULTS COMPARED TO PREVIOUSLY TESTED RESULTS ON THE SAME DEVICE. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.