DIMENSION EXL WITH LM
Received Nov 18, 2014 · Event occurred Oct 24, 2014
Report 1226181-2014-00589 · MDR key 4259255
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Siemens Healthcare Diagnostics IncModel number
DIMENSION EXL WITH LMProduct problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT CONTROLS WERE WITHIN RANGE AND NO ERRORS OCCURRED AT THE TIME OF EVENT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED K RESULT IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING ON THE SAME INSTRUMENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
A DISCORDANT, FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED K RESULT.