DCA VANTAGE
Received Oct 26, 2020 · Event occurred Oct 9, 2020
Report 3002637618-2020-00058 · MDR key 10733700
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE OPERATOR STATED, "I HAVE CLEANED MY EYES, AND CONFIRMED THAT THERE IS NO PROBLEM AT THIS TIME." THE OPERATOR WAS TOLD THAT, "IF POSSIBLE, COME TO AN OPHTHALMOLOGIST AND BRING THE PACKAGE INSERT." PER THE HBA1C SDS, "THIS MATERIAL IS NOT CONSIDERED HAZARDOUS." THE OPERATOR WAS TREATED BY AN OPHTHALMOLOGIST, AND CONFIRMED THAT THERE WAS NO HEALTH HAZARD. AS PER THE OPERATOR'S GUIDE: "WEAR PERSONAL PROTECTIVE EQUIPMENT, INCLUDING SAFETY GLASSES AND GLOVES. USE UNIVERSAL PRECAUTIONS." THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT. IN ADDITION, PROPER TECHNIQUE WAS NOT FOLLOWED. THE CUSTOMER STATED THAT AFTER THE OPERATOR INSERTED THE REAGENT CARTRIDGE INTO THE DEVICE, HE PULLED OUT THE FLEXIBLE TAB VIGOROUSLY. THE HBA1C QUICK REFERENCE GUIDE INSTRUCTS THE OPERATOR TO, "SLOWLY AND SMOOTHLY PULL TO REMOVE THE FLEXIBLE TAB." THIS MDR IS FILED OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
THE CUSTOMER REPORTED THAT AFTER THE OPERATOR INSERTED THE HBA1C REAGENT CARTRIDGE INTO THE DCA VANTAGE DEVICE, THE OPERATOR PULLED OUT THE FLEXIBLE TAB VIGOROUSLY, AND THE REAGENT SCATTERED FROM THE REAGENT CARTRIDGE, AND ENTERED THE OPERATOR'S RIGHT EYE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.