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Patient 1
THIS EVENT WAS REPORTED TO MHRA BY THE CUSTOMER PRIOR TO EPOCAL BEING NOTIFIED OF THE EVENT. REPORTER CONFIRMED THAT NO INJURY/ADVERSE EVENT HAPPENED, HOWEVER WE WERE UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER DESPITE THREE ATTEMPTS AT FOLLOW-UP. EPOCAL CANNOT RULE OUT THE POSSIBILITY OF A SERIOUS DETERIORATION IN THE STATE OF HEALTH IF THE EVENT WERE TO RECUR. DESPITE THREE ATTEMPTS AT FOLLOW-UP WITH THE REPORTING INSTITUTION, THE COMPANY WAS UNABLE TO CONFIRM THAT AN EPOC DEVICE WAS INVOLVED IN THIS EVENT OR TO OBTAIN LOT NUMBERS INVOLVED OR RELEVANT INFORMATION (SAMPLE HANDLING DETAILS, OBTAINED PO2 RESULTS WITH EPOC AND COMPARATIVE INSTRUMENT, EXPECTED PO2 VALUE, ANY PATIENT CONDITION AT THE TIME OF TESTING) IN ORDER TO INVESTIGATE FURTHER. ALTHOUGH NO PATIENT INJURY OCCURRED, THE INITIAL REPORTER CLASSIFIED THE INCIDENT AS A NEAR MISS, THEREFORE THE COMPANY IS REPORTING THIS EVENT ON THE ASSUMPTION THAT IF THE EVENT WERE TO RECUR IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DETERIORATION IN STATE OF HEALTH. COMPLAINT HISTORY RESULTS: FOR THE PERIOD (B)(6) 2018 TO (B)(6) 2018, THERE WAS ONE OTHER COMPLAINT RELATED TO A HIGH PO2 BIAS RECEIVED BY THE MANUFACTURER IN ADDITION TO THIS CASE REPORTED TO MHRA. THE OTHER COMPLAINT WAS INITIATED IN (B)(6) AND THE MANUFACTURER INVESTIGATION REVEALED THAT THE REPORTED BIAS WAS IN FACT WITHIN PRODUCT SPECIFICATIONS (ALLOWABLE TOTAL ERROR). PRE-ANALYTICAL FACTORS WERE ALSO NOTED (DELAY IN TESTING). THE MANUFACTURER HAS NOT BEEN NOTIFIED OF ANY ADVERSE EVENTS RELATED TO HIGH PO2 RESULTS. MALFUNCTION COULD NOT BE CONFIRMED AS NO LOT INFORMATION OR DATA WAS PROVIDED BY THE REPORTING INSTITUTION. BASED ON THE IN-HOUSE PERFORMANCE DATA AS WELL AS RECEIVED COMPLAINTS, NO EVIDENCE OF A PRODUCT PERFORMANCE ISSUE IS FOUND.(B)(4).