ISE 9180
Received Sep 12, 2013 · Event occurred Jul 30, 2013
Report 1823260-2013-05648 · MDR key 3345789
Device
Generic name
Blood Gas Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03157334001
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) LITHIUM RESULTS FOR THREE PATIENT SAMPLES. DATA WAS ONLY PROVIDED FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 1.41 MEQ/L AND WAS REPORTED OUTSIDE THE LABORATORY. THEY CALLED THE NURSES TO STOP THEM FROM TREATING THE PATIENT AND SENT THE SAMPLE OUT TO ANOTHER LAB TO BE TESTED. THE CUSTOMER BELIEVED THE OTHER LABORATORY ALSO USED A ROCHE 9180 ANALYZER. THE REPEAT RESULT WAS 0.66 MEQ/L AND WAS USED TO TREAT THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE LITHIUM ELECTRODE LOT NUMBER WAS 21524641 WITH AN EXPIRATION DATE OF 05/31/2013. IT WAS NOTED THE CUSTOMER HAD INSTALLED THE LITHIUM ELECTRODE ON (B)(4) 2013 WHICH WAS AFTER THE RECOMMENDED DATE FOR USE. THE CUSTOMER WAS ADVISED TO REPLACE THE ELECTRODES.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Additional Manufacturer Narrative
THE CUSTOMER REPLACED THE ELECTRODES AND STATED THE ISSUE WAS RESOLVED.