ROCHE 9180 ELECTROLYTE ANALYZER
Received Oct 17, 2018 · Event occurred Sep 28, 2018
Report 1823260-2018-03711 · MDR key 7973214
Device
Generic name
Electrolyte Analyzer
Manufacturer
Roche DiagnosticsModel number
ISE 9180Catalog number
03157334001
Lot number
NA
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE CALCIUM RESULTS FROM THE ELECTROLYTE ANALYZER 9180 THAT WOULD BE 10X THE NORMAL RESULT. ONE EXAMPLE WAS PROVIDED. THE RESULTS FOR ONE SAMPLE WERE 0.44 MMOL/L, 0.44 MMOL/L AND 4.68 MMOL/L. THE RESULT OF 0.44 MMOL/L WAS BELIEVED TO BE CORRECT. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. ALL QC RESULTS WERE IN THE ACCEPTABLE RANGE. THE CUSTOMER REPLACED ALL THE ELECTRODES, ALL TUBING, AND SNAPACK. HOWEVER, THE ISSUE WAS NOT RESOLVED. THE CUSTOMER THEN CHANGED THE CALCIUM ELECTRODE AND RAN A 20 SPECIMEN VALIDATION.
Additional Manufacturer Narrative
THE CUSTOMER WAS SENT A REPLACEMENT INSTRUMENT. THE MAINBOARD FROM THE AFFECTED SYSTEM WAS RETURNED TO ROCHE DIAGNOSTICS FOR FURTHER INVESTIGATION. THE ISSUE COULD NOT BE REPRODUCED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.