ISE 9180
Received Jan 6, 2015 · Event occurred Dec 12, 2014
Report 1823260-2015-00058 · MDR key 4386781
Device
Generic name
Blood Gas Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05110394001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THERE WERE NO ADVERSE EVENTS. ONLY THE 123 MMOL/L RESULT WAS REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
THE EVENT TOOK PLACE IN (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF A QUESTIONABLE ION SELECTIVE ELECTRODE SODIUM RESULT. THE INITIAL RESULT WAS 90 MMOL/L. THE REPEAT RESULT WAS 123 MMOL/L. INFORMATION REGARDING WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND WHETHER THE PATIENT WAS HARMED WAS REQUESTED BUT NOT PROVIDED. THE LOT NUMBER AND EXPIRATION DATE OF THE SODIUM ELECTRODE WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ANALYZER WAS NOT APPROPRIATELY GROUNDED. AFTER THE CUSTOMER CORRECTED THE GROUNDING ISSUE, SAMPLES WERE TESTED AND THE RESULTS WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ANALYZER WAS WORKING PROPERLY.