DCA VANTAGE
Received Mar 19, 2026 · Event occurred Feb 6, 2026
Report 3002637618-2026-00019 · MDR key 24636121
Device
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION. TESTING WAS PERFORMED ON RETURNED REAGENT USING IN-HOUSE DCA VANTAGE INSTRUMENTS AND ANALYSIS WAS COMPLETED USING TEST SOLUTION TWO, WHICH HAS AN ASSIGNED VALUE OF 8.31%. ALL HBA1C RESULT VALUES WERE RECORDED AND COMPARED TO THE COMPLAINT AS WELL AS THEIR EXPECTED VALUES. THE CUSTOMER'S REPORT OF LOW BIAS HBA1C RESULT WAS NOT REPRODUCED. CUSTOMER STATES THAT QUALITY CONTROL IS PASSING, AND THEY ARE OPERATIONAL. THE CAUSE OF THE EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.
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. THE CONTROLS WERE PASSING. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.