ROCHE 9180 ELECTROLYTE ANALYZER
Received Feb 28, 2022 · Event occurred Feb 4, 2022
Report 1823260-2022-00539 · MDR key 13620296
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
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER STATED THE CALIBRATION WERE OK, BUT QC SOMETIMES FAILED. THE REAGENTS WERE REPLACED ON (B)(6) 2022. THE ELECTRODES WERE REPLACED AT THE END OF (B)(6) 2021. THE CUSTOMER WAS ADVISED TO CLEAN PORTS AND PROBES AND ALSO MIX INTERNAL FLUID OF THE ELECTRODES. DUE TO THE LACK OF DATA THAT WAS PROVIDED, FURTHER INVESTIGATION COULD NOT BE PERFORMED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LI+ ELECTRODE RESULTS FOR 1 PATIENT SAMPLE AND QUESTIONABLE NA+ ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A ROCHE 9180 ELECTROLYTE ANALYZER. PATIENT 1: THE INITIAL LITHIUM RESULT WAS 0.7 MMOL/L AND THE REPEATED RESULT WAS 0.5 MMOL/L. PATIENT 2: THE INITIAL SODIUM RESULT WAS 139 MMOL/L AND THE REPEATED RESULT WAS 147 MMOL/L. IT IS UNKNOWN IF THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED.