DCA VANTAGE
Received Apr 30, 2026 · Event occurred Mar 27, 2026
Report 3002637618-2026-00051 · MDR key 25039385
Device
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AVAILABLE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED; NO ADDITIONAL INFORMATION WAS AVAILABLE FOR ASSESSMENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO EVIDENCE TO SUGGEST ABNORMAL INSTRUMENT PERFORMANCE. THOUGH THE CUSTOMER STATED THEY FOLLOWED PROPER MAINTENANCE AND TECHNIQUE, THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ABOUT MEDICATION OR OTHER FACTORS THAT MAY INFLUENCE THE RESULTS. ADDITIONALLY, THE CUSTOMER WAS UNABLE TO PROVIDE THE REAGENT LOT DETAILS USED AT THE TIME OF INCIDENT FOR FURTHER INVESTIGATION. NO SYSTEMIC ISSUES WERE IDENTIFIED BASED ON THE AVAILABLE INFORMATION. THE CAUSE OF THE EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.
Additional Manufacturer Narrative
THE AVAILABLE INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED; NO ADDITIONAL INFORMATION WAS AVAILABLE FOR ASSESSMENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO EVIDENCE TO SUGGEST ABNORMAL INSTRUMENT PERFORMANCE. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ABOUT REAGENT LOT NUMBER, MEDICATION OR OTHER FACTORS THAT MAY INFLUENCE THE RESULTS. WITHOUT THE REQUESTED INFORMATION THE ROOT CAUSE COULD NOT BE DETERMINED. NO SYSTEMIC ISSUES WERE IDENTIFIED BASED ON THE AVAILABLE INFORMATION. THE CAUSE OF THIS EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSELY ELEVATED HBA1C RESULT COMPARED TO RETESTING ON THE SAME DEVICE AND BY UNKNOWN LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.