RAPIDPOINT 500E BLOOD GAS SYSTEM
Received Oct 4, 2023 · Event occurred Sep 21, 2023
Report 3002637618-2023-00080 · MDR key 17868958
Device
Generic name
Rp 500e
Catalog number
11416755
Product problems
- Low Test Results
- Low Test Results
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER ALLEGES MULTIPLE DISCREPANT LOW K+ RESULTS COMPARED TO RETESTING OF A NEW SERUM SAMPLE ON A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
THE CUSTOMER HAS PROVIDED INSTRUMENT FILES FOR FURTHER INVESTIGATION. INVESTIGATION IS UNDERWAY. THE CUSTOMER REPLACED THEIR MEASUREMENT CARTRIDGE AND ARE CURRENTLY OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION. THE CUSTOMER PROVIDED INSTRUMENT LOG FILES, AUTOMATIC QUALITY CONTROL (AQC) FILES AND SENSOR FILES. A REVIEW OF THIS DATA INDICATES THAT THE POTASSIUM SENSOR WAS PERFORMING AS INTENDED AT TIME OF ANALYSIS ON THE ESCALATED SAMPLES. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES RELATED TO POTASSIUM SENSOR PERFORMANCE. IT SHOULD BE NOTED THAT PRE-ANALYTICS SUCH AS DIFFERENCES IN MATRICES (SERUM VS WHOLE BLOOD), COLLECTION PRACTICES, SAMPLE INHOMOGENEITY, AND TIME DIFFERENCES BETWEEN COMPARATIVE MEASUREMENTS MAY PLAY A PART OF THE OBSERVED DIFFERENCE BETWEEN THE RESULTS. THE MEASUREMENT CARTRIDGE WAS REPLACED, AND THE CUSTOMER IS OPERATIONAL. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THERE IS NO INDICATION THAT THE INSTRUMENT IS NOT OPERATING AS INTENDED.