DIMENSION EXL
Received May 8, 2013 · Event occurred Apr 5, 2013
Report 1226181-2013-00210 · MDR key 3100871
Device
Generic name
Clinical Chemistry System
Manufacturer
Siemens Healthcare DiagnosticsModel number
DIMENSION EXLProduct problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND ANALYZED THE INSTRUMENT AND INSTRUMENT DATA. THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT SODIUM AND POTASSIUM RESULTS WERE DUE TO USER ERROR; IMPROPER SAMPLE TUBE SPINNING. THE TUBE VENDOR RECOMMENDS PULLING 100 - 1300 G FORCE FOR 10 MINUTES IN ORDER TO GET A CLEAN SAMPLE. SIEMENS INSTRUCTED THE CUSTOMER TO FOLLOW THE TUBE MANUFACTURER'S RECOMMENDATION FOR PROPER CENTRIFUGATION TIMES AND SPEEDS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.
Description of Event or Problem
DISCORDANT SODIUM (NA) AND POTASSIUM (K) RESULTS WERE OBTAINED ON A DIMENSION EXL INSTRUMENT FOR THREE PATIENTS. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIANS. THE SAMPLES WERE RETESTED AND THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM AND POTASSIUM RESULTS.