ROCHE 9180 ELECTROLYTE ANALYZER
Received Mar 10, 2020 · Event occurred Feb 20, 2020
Report 1823260-2020-00700 · MDR key 9813123
Device
Generic name
Electrolyte Analyzer
Manufacturer
Roche DiagnosticsModel number
ISE 9180Catalog number
03157334001
Lot number
NA
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THE ELECTRODES WERE EXPIRED. THE ELECTRODES WERE REPLACED AROUND (B)(6) 2020 AND THE CUSTOMER STATES THE INSTRUMENT HAS WORKED OK. ONE LEVEL OF CONTROL FAILED AFTER THE COMPLAINED SAMPLE MEASUREMENTS. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH THE USE OF EXPIRED ELECTRODES.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR SODIUM, POTASSIUM, AND CALCIUM ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED WITH A SODIUM VALUE OF 109 MMOL/L ACCOMPANIED BY A DATA FLAG, WHICH REPEATED AS 118 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE INITIALLY RESULTED WITH A POTASSIUM VALUE OF 5.3 MMOL/L ACCOMPANIED BY A DATA FLAG, WHICH REPEATED AS 3.2 MMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE INITIALLY RESULTED WITH A CALCIUM VALUE OF 0.96 MMOL/L ACCOMPANIED BY A DATA FLAG, WHICH REPEATED AS 1.16 MMOL/L. THE SODIUM, POTASSIUM, AND CHLORIDE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED.