ICHEMVELOCITY URINE CHEMISTRY SYSTEM
Received Mar 17, 2017 · Event occurred Feb 8, 2017
Report 6413119 · MDR key 6413119
Device
Generic name
Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Manufacturer
Iris International, Inc.Model number
VELOCITYProduct problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
STAFF NOTICED SEVERAL PATIENTS WERE OBTAINING POSITIVE URINE GLUCOSE RESULTS OF 50 ON THE VELOCITY ANALYZER. SEVERAL OF THESE PATIENTS HAD TESTS REPEATED ON THE BACK-UP ANALYZER AND THEN OBTAINED A NEGATIVE VALUE. AT THIS POINT, THE INSTRUMENT WAS TAKEN OUT OF SERVICE AND THE BACK-UP ANALYZER WAS PUT INTO USE. SERVICE ARRIVED TWO DAYS LATER AND WE THOUGHT THE ISSUE WAS RESOLVED, HOWEVER THE POSITIVE GLUCOSES RETURNED THAT EVENING AND INSTRUMENT WAS AGAIN TAKEN OUT OF SERVICE. SERVICE ARRIVED AGAIN AND PROBLEM WAS RESOLVED FIVE DAYS AFTER THE INITIAL INCIDENT. IT WAS DETERMINED THAT THE SAMPLE PROBE WASN'T BEING COMPLETELY WASHED OF PATIENT SAMPLES IN BETWEEN ASPIRATIONS AND RESULTS WERE CARRYING OVER FROM PREVIOUS SAMPLES. MANUFACTURER RESPONSE: FOR IRIS VELOCITY URINE CHEMISTRY ANALYZER, BECKMAN IRIS (PER SITE REPORTER)