ROCHE 9180 ELECTROLYTE ANALYZER
Received Sep 14, 2018 · Event occurred Aug 28, 2018
Report 1823260-2018-03149 · MDR key 7877768
Device
Generic name
Electrolyte Analyzer
Manufacturer
Roche DiagnosticsModel number
ISE 9180Catalog number
ASKU
Lot number
NA
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF DISCREPANT ISE INDIRECT NA FOR GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A ROCHE 9180 ELECTROLYTE ANALYZER COMPARED TO AN ELYTE INSTRUMENT. THE NA RESULT WAS 132 MMOL/L ON THE 9180 ELECTROLYTE ANALYZER. THE NA RESULT WAS 141 MMOL/L ON THE ELYTE INSTRUMENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PERFORMED DAILY MAINTENANCE AND CALIBRATION. THE CUSTOMER REPEATED THE SAMPLE. THE REPEAT NA RESULT WAS 137 MMOL/L ON THE 9180 ELECTROLYTE ANALYZER AND 142 MMOL/L ON THE ELYTE INSTRUMENT. THE NA ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.
Additional Manufacturer Narrative
THE REFERENCE ELECTRODE WAS INSTALLED (B)(6) 2018. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.