DIMENSION VISTA 1500
Received Nov 18, 2014 · Event occurred Oct 21, 2014
Report 1226181-2014-00594 · MDR key 4257071
Device
Generic name
Clinical Chemistry System
Manufacturer
Siemens Healthcare DiagnosticsModel number
DIMENSION VISTA 1500Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A DISCORDANT, FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT K RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. THE SAME SAMPLE WAS REPEATED TWO TIMES ON ALTERNATE INSTRUMENTS, BOTH RESULTING LOWER. IT IS UNKNOWN AS TO WHICH REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT K RESULT.
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER INSTRUMENT AND INSTRUMENT DATA EVALUATION, THE CSE DETERMINED THAT THERE WAS NO INSTRUMENT MALFUNCTION DURING THE TIME OF THE EVENT. THE HEADQUARTERS SUPPORT CENTER DETERMINED THAT THE POTASSIUM SAMPLE WAS PROCESSED PRE-CENTRIFUGED, WHICH INDICATES THE SAMPLE UNDERWENT POOR PRE-ANALYTICAL SAMPLE HANDLING. THE CAUSE OF THE DISCORDANT POTASSIUM RESULT IS UNKNOWN. THE CUSTOMER SUCCESSFULLY REPEATED THE POTASSIUM RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.