ROCHE 9180 ELECTROLYTE ANALYZER
Received Aug 6, 2018 · Event occurred Jul 20, 2018
Report 1823260-2018-02623 · MDR key 7752893
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
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR POTASSIUM ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE RESULTED WITH A POTASSIUM VALUE OF 6.7 MMOL/L WHEN TESTED ON THE 9180. THE SAMPLE WAS REPEATED ON AN ISTAT ANALYZER, RESULTING AS 4.6 MMOL/L. BOTH VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED.
Additional Manufacturer Narrative
NO QC RESULTS OR DATA WERE PROVIDED. THE PRODUCT WAS REQUESTED FOR INVESTIGATION BUT NOT RETURNED. THE CUSTOMER CONTINUED USING THE AFFECTED ELECTRODE, AND THERE WERE NO FURTHER ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.