Description of Event or Problem · 1
(B)(4) (A DISTRIBUTOR OF DATA INNOVATIONS' INSTRUMENT MANAGER SOFTWARE) REPORTED AN EVENT TO DATA INNOVATIONS (DI) ON BEHALF OF (B)(6) ON (B)(6) 2021. A CRITICAL RESULT WAS REPORTED TO THE WRONG CAREGIVER DUE TO AN INCORRECT ROOM NUMBER. THE SITE CONFIRMED THAT WHEN THE CRITICAL RESULT WAS REPORTED, THE CORRECT PATIENT NAME, DOB, TEST AND RESULT WERE PROVIDED TO THE CAREGIVER. BASED ON THE RESULT, THE CRITICAL VALUE WAS ACTED UPON FOR THE INCORRECT PATIENT. A CAREGIVER REPORTED THAT THE PATIENT CHART WAS NOT UPDATED. INVESTIGATION AT THE CUSTOMER SITE DETERMINED THE RESULT WAS GIVEN TO THE INCORRECT CAREGIVER BASED ON THE ROOM AND LOCATION, RESULTING IN A 6-HOUR DELAY IN TREATMENT ON THE CORRECT PATIENT. NO PATIENT HARM ON EITHER PATIENT WAS REPORTED TO DI. THIS WAS NOT A MALFUNCTION OF INSTRUMENT MANAGER. REPORT IS BEING SUBMITTED DUE TO THE INCORRECT PATIENT BEING UNNECESSARILY TREATED. FDA SAFETY REPORT ID# (B)(4).