EVO ADDITIONAL P MODULE
Received Feb 25, 2010 · Event occurred Jan 29, 2010
Report 1823260-2010-01261 · MDR key 1616070
Device
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
USER RECEIVED AN ERRONEOUS PHOSPHORUS RESULT FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 16.3 MG/DL AND WAS REPORTED OUT. USER STATED "AFTER BEING ALERTED TO THE ISSUE THEY REPEATED THE SAMPLE". SAMPLE WAS REPEATED ON ANOTHER P MODULE SERIAL NUMBER (B) (4) AT THE SITE GIVING 3.9 MG/DL AND WAS BELIEVED TO BE THE CORRECT RESULT. NO INFORMATION COULD BE PROVIDED IF PATIENT WAS ADVERSELY AFFECTED. PHOSPHORUS REAGENT LOT NUMBERS: R1 61225901, R2 61480601. THE FIELD SERVICE REPRESENTATIVE SUSPECTED A REAGENT SPILL ON THE REACTION CUVETTES AS THE CAUSE. HE REPLACED CELLS, RAN CELL BLANK AND CHECKED REAGENT PROBE ALIGNMENT. TO VERIFY ANALYZER PERFORMANCE A 25 CUP PRECISION STUDY USING A PATIENT POOL WAS RUN WHICH GAVE ACCEPTABLE RESULTS.
Additional Manufacturer Narrative
IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.