RAPIDPOINT 405
Received Nov 2, 2012 · Event occurred Oct 1, 2012
Report 1217157-2012-00054 · MDR key 2831302
Device
Generic name
Rapidpoint 405
Model number
405Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTS THEY TESTED AN ARTERIAL SYRINGE SAMPLE TODAY AND THE ELECTROLYTE RESULTS WERE ABNORMAL. THEY REPEATED THE TESTING ON THE SAME SAMPLE AND THE RESULTS WERE NORMAL. THEY RAN THE SAME SAMPLE ON ANOTHER RP405 INSTRUMENT AND THE RESULTS WERE NORMAL AND MATCHED THE REPEAT RESULTS ON THE INITIAL TESTING. QUESTIONABLE RESULT WAS NOT REPORTED. THERE WAS NO IMPACT TO THE PT. NO TREATMENT WAS REQUIRED, DELAYED OR WITHHELD AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
CUSTOMER STOPPED USING THE ANALYZER IN QUESTION, BUT DID RUN ADD'L SAMPLES FOR TESTING PURPOSES. EACH TIME THE INITIAL ELECTROLYTE RESULTS WERE ABNORMAL BUT NORMAL UPON REPEAT TESTING. THE AQC WAS LAST RUN 6 HRS PREVIOUS TO INITIAL ABNORMAL TEST RESULTS. SYSTEM WAS RECALIBRATED AND AQC SAMPLE TESTED. ALL AQC RESULTS WERE IN RANGE. EVENTS LOG WAS REVIEWED AND NO RECENT ERRORS WERE REPORTED. CUSTOMER WAS ADVISED TO REPLACE MEASUREMENT CARTRIDGE AND PERFORM PT STUDY BEFORE USING INSTRUMENT.