OMNI

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

A NURSE AT THE CUSTOMER SITE COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR THB AND HCT ON THE B221 ANALYZER LOCATED IN THE INTENSIVE CARE UNIT (ICU). THE INITIAL THB RESULT WAS 15.6 G/DL. THE REPEAT THB RESULT 5 MINUTES LATER WAS 8.4 G/DL. THE INITIAL HCT RESULT 42.7%. THE REPEAT HCT RESULT 5 MINUTES LATER WAS 19.0%. A COMPLETE BLOOD COUNT (CBC) WAS RUN AT THIS TIME AND THE THB RESULT WAS 9.5 G/DL AND THE HCT RESULT WAS 27.6%. NO ADVERSE EVENT WAS REPORTED. THE PATIENT HAS BEEN MOVED OUT OF THE ICU. QUALITY CONTROLS WERE ACCEPTABLE. THE CUSTOMER MONITORED SAMPLES BEING MEASURED ON THE ANALYZER THE DAY AFTER THE EVENT AND NO ABNORMAL RESULTS OCCURRED.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A GENERAL INSTRUMENT RELATED ISSUE CAN BE EXCLUDED. A POTENTIAL SAMPLE RELATED ISSUE WAS IDENTIFIED. THE NURSE DID NOT MIX THE SAMPLE AGAIN BEFORE IT WAS ANALYZED. THE ROOT CAUSE MAY BE RELATED TO A PRE-ANALYTIC ISSUE SUCH AS SEDIMENTATION.