STAT PROFILE® PRIME PLUS ANALYZER SYSTEM

Description of Event or Problem

NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING MISSING CO-OXIMETRY RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME PLUS ANALYZER WITH SERIAL NUMBER (B)(4). IT WAS REPORTED THE PATIENT ARRIVED INTUBATED AND WAS PRESUMED TO BE INTOXICATED LEADING TO SEVERE METHEMOGLOBINEMIA. THE PRIME PLUS ANALYZER DID NOT PRODUCE CO-OXIMETRY RESULTS WHEN RUNNING A SAMPLE AND INSTEAD DISPLAYED A "RESULTS SUSPECT" MESSAGE. THIS SAMPLE WAS RUN ON AN ADDITIONAL ANALYZER WHICH CONFIRMED THE "RESULTS SUSPECT". AFTER THREE ATTEMPTS AT RUNNING A SAMPLE, A METHEMOGLOBIN VALUE OF 55% WAS RECEIVED. WITHOUT CONFIRMATION OF THE DIAGNOSIS, THE PATIENT WAS TREATED BASED ON CLINICAL PRESENTATION. THE PATIENT LATER WENT INTO CARDIAC ARREST AND DID NOT RECOVER AFTER CARDIOPULMONARY RESUSCITATION.

Additional Manufacturer Narrative

UDI: (B)(4). THE DISTRIBUTOR REPORTED AN INCIDENT WHERE A CO-OXIMETRY RESULT WAS NOT RECEIVED WHILE TREATING A TIME-SENSITIVE PATIENT WITH A STATPROFILE PRIME PLUS ANALYZER, SERIAL NUMBER (B)(4). THIS OCCURRED ON (B)(6) 2021. THE ANALYZER DID NOT PRODUCE A RESULT AND INSTEAD PRODUCED A MESSAGE SAYING "RESULTS SUSPECT". THE CUSTOMER INDICATED THE LACK OF RESULTS DELAYED THE CONFIRMATION OF THE PATIENT'S DIAGNOSIS OVER A 90 MINUTE PERIOD. THE PATIENT WAS TREATED FOR SEVERE METHEMOGLOBINEMIA BUT LATER SUFFERED CARDIAC ARREST AND COULD NOT BE REVIVED. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE ANALYZER AND THE CONSUMABLES IN USE AT THE TIME OF THE EVENT BY A QUALITY CONTROL ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE ANALYZER AND CONSUMABLES. NO ABNORMALITIES OR CONCERNS WERE NOTED, AND THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE CONCLUSION OF THE INVESTIGATION IS THE REPORTED CUSTOMER COMPLAINT CONFIRMS THE ANALYZER FUNCTIONED APPROPRIATELY. AS STATED IN THE INSTRUCTIONS FOR USE, THE ERROR CODE, "COOX DATA SUSPECT," DISPLAYS WHEN THE ANALYZER IS UNABLE TO ACCURATELY PRODUCE A TEST RESULT BECAUSE OF A POSSIBLE INTERFERENT WITHIN THE SAMPLE. THIS SUSPICION WAS CONFIRMED WHEN THE SAME, "DATA SUSPECT," RESULT WAS RECEIVED ON A REFERENCE ANALYZER USING MULTIPLE SAMPLES FROM THE SAME PATIENT. THE ANALYZER AND CONSUMABLES WORKED AS INTENDED BY DISPLAYING THIS ERROR CODE AND NOT DISPLAYING AN INACCURATE RESULT. NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.