CLINITEK 500 ANALYZER
Received May 7, 2014 · Event occurred Apr 5, 2014
Report 1217157-2014-00066 · MDR key 3796806
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CAUSE FOR THE RED OR BROWN COLOR ON THEIR INSTRUMENT IS UNKNOWN.
Additional Manufacturer Narrative
CUSTOMER INDICATED AFTER REVIEWING TECHNIQUE AND CLEANING INSTRUMENT RESOLVED THIS ISSUE. INSTRUMENT IS FULLY OPERATIONAL. THIS DATA WAS REVIEWED WITH SIEMENS MEDICAL AFFAIRS WITH FOLLOWING CONCLUSION: ABNORMAL COLOR OF URINE REQUIRES FURTHER EVIDENCE OF A PATHOLOGIC STATE. SINCE THE RESULTS ARE NOT AFFECTED THE COLOR DOES NOT INSTIGATE FURTHER INVESTIGATION. BECAUSE THIS ADDITIONAL INFORMATION WAS NOT AVAILABLE FOR THE INITIAL FILED MDR, THE MDR 1217157-2014-00066 WAS FILED. HAD THIS ADDITIONAL INFORMATION BEEN AVAILABLE, THIS EVENT WOULD HAVE BEEN ASSESSED AS NOT REQUIRE FILING MDR AS PER 21 CFR 803.
Description of Event or Problem
CUSTOMER REPORTED APPROXIMATELY 30% OF PATIENT RESULTS ARE COMING BACK AS A RED OR BROWN COLOR ON THEIR INSTRUMENT. COLOR IS REPORTED BY THE INSTRUMENT AND ALL SAMPLES ARE NORMAL YELLOW COLOR BY VISUAL INSPECTION. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.