ROCHE 9180 ELECTROLYTE ANALYZER
Received Jun 11, 2020 · Event occurred May 13, 2020
Report 1823260-2020-01424 · MDR key 10142439
Device
Generic name
Electrolyte Analyzer
Manufacturer
Roche DiagnosticsModel number
ISE 9180Catalog number
03157334001
Lot number
NA
Product problems
- Low Test Results
- Low Test Results
Patient
15 MO
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT RESULT FOR ONE PATIENT TESTED FOR IONIZED CALCIUM ON THE 9180 ELECTROLYTE ANALYZER. ON THE NIGHT OF (B)(6) 2020, THE REPORTER STATED THERE WERE ISSUES WITH CALIBRATION OF THE 9180 ANALYZER AND A SYSTEM REAGENT PACK HAD LEAKED. CLEANING WAS PERFORMED AND THE REPORTER CONTINUED TO TRY RECALIBRATING UNTIL CALIBRATION WAS SUCCESSFUL. THE SAMPLE INITIALLY RESULTED WITH AN IONIZED CALCIUM VALUE OF 1.52 MG/DL WHEN TESTED ON THE 9180 ANALYZER. THE PATIENT HAD NO PREVIOUS RESULTS, SO THE SAMPLE WAS REPEATED ON AN ABL 800 GASOMETER, RESULTING WITH AN IONIZED CALCIUM VALUE OF 5.04 MG/DL. THIS VALUE WAS CONSIDERED CORRECT AND RELEASED TO THE DOCTOR. THE IONIZED CALCIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.