MalfunctionLCP
DCA VANTAGE
Received Jul 6, 2026 · Event occurred May 26, 2026
Report 3002637618-2026-00081 · MDR key 25713580
Device
Product problems
- Low 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 DEPRESSED HBA1C RESULT COMPARED TO RETESTING ON AN UNKNOWN LAB INSTRUMENT. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.