9180 ELECTROLYTE ANALYZER
Received Aug 30, 2024 · Event occurred Aug 9, 2024
Report 1823260-2024-02522 · MDR key 20110886
Device
Product problems
- Output Problem
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE NA ELECTRODE EXPIRATION DATE WAS 27-SEP-2024. THE SAMPLES WERE SERUM SAMPLES. THE MAINTENANCE OF THE INSTRUMENT WAS LAST PERFORMED ON 20-OCT-2023 AND IT WAS UP TO DATE. THE CLEANING AND CONDITIONING WERE PERFORMED DAILY. THE FIELD SERVICE ENGINEER REPLACED THE MAIN HARNESS, QUAD-RING, AND O-RING. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE NA ELECTRODE LOT NUMBER IS 31235147. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND CRYSTALLIZATION ON THE SNAP PACK RUBBER CONNECTOR AND THE ELECTRODE HOLDER/SAMPLE SENSOR AND ALSO FOUND BUBBLING IN THE PUMP TUBES AND A NICK IN THE RUBBER O-RING OF AN ELECTRODE. THE FSE CLEANED THE SYSTEM AND REPLACED THE NA ELECTRODE, A SYRINGE, THE HARNESS AND MAIN TUBING, A QUAD RING, AND AN ELECTRODE SEAL. THE FSE PERFORMED MECHANICAL AND PERFORMANCE CHECKS, CALIBRATION, AND QC SUCCESSFULLY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 5 PATIENT SAMPLES ON A 9180 ELECTROLYTE ANALYZER. ON 09-AUG-2024, SAMPLE 1 HAD AN INITIAL RESULT OF 147 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 201 MMOL/L, 156 MMOL/L, 146 MMOL/L, 147 MMOL/L, AND 146 MMOL/L. ON 09-AUG-2024, SAMPLE 2 HAD AN INITIAL RESULT OF 132 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 108 MMOL/L, 130 MMOL/L, 127 MMOL/L, 117 MMOL/L, AND 130 MMOL/L. ON 09-AUG-2024, SAMPLE 3 HAD AN INITIAL RESULT OF 118 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 143 MMOL/L, 118 MMOL/L, 116 MMOL/L, 116 MMOL, AND 116 MMOL/L. THE CUSTOMER CHANGED THE SNAP PACK, REFERENCE ELECTRODE, AND ELECTRODE HOUSING PRIOR TO RUNNING THE FOLLOWING TWO SAMPLES. ON 19-AUG-2024, SAMPLE 4 HAD AN INITIAL RESULT OF 118 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 112 MMOL/L, 114 MMOL/L, 115 MMOL/L, 117 MMOL/L, 118 MMOL/L, AND 117 MMOL/L. ON 19-AUG-2024, SAMPLE 5 HAD AN INITIAL RESULT OF 120 MMOL/L. THE SAMPLE WAS REPEATED AND THE RESULTS WERE 118 MMOL/L, 114 MMOL/L, 118 MMOL/L, 118 MMOL/L, 118 MMOL/L, AND 118 MMOL/L.