THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS USING 3 DIFFERENT LOTS OF VITROS PHENYTOIN (PHYT) MICRO SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. HISTORICAL QUALITY CONTROL RESULTS INDICATED THAT THREE OF THE FOUR VITROS PHYT SLIDE LOTS WERE EXHIBITING SOME MAGNITUDE OF WITHIN-LAB IMPRECISION WITHIN THE TIMEFRAME OF THE EVENT. SINCE THREE DIFFERENT VITROS PHYT SLIDE LOTS WERE AFFECTED, IT IS UNLIKELY A SLIDE RELATED ISSUE CONTRIBUTED TO THE EVENT, HOWEVER, SLIDE RELATED ISSUES CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. IN ADDITION, ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS PHYT REAGENT. THE TSC DID NOT INVESTIGATE THE CUSTOMER?S SAMPLE HANDLING PROTOCOL, THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE HANDLING PROTOCOL CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. FINALLY, AN ORTHO FE REPLACED THE IMMUNOWASH METERING PUMP OF THE VITROS 5600 SYSTEM, HOWEVER, SINCE THE PRE-SERVICE VITROS CRBM AND PHYT WITHIN-RUN PRECISION TESTS WERE ACCEPTABLE, IT IS UNKNOWN IF AN ANALYZER RELATED ISSUE CONTRIBUTED TO THE EVENT. ACCEPTABLE VITROS PHYT PERFORMANCE HAS BEEN OBSERVED SINCE THE SERVICE ACTION PERFORMED ON 14 JUNE 2018.
D
Patient 1
A CUSTOMER OBTAINED LOWER AND HIGHER THAN EXPECTED RESULTS FROM QUALITY CONTROL FLUIDS USING 3 DIFFERENT LOTS OF VITROS PHENYTOIN (PHYT) MICRO SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PHYT SLIDE LOT 2615-0166-7348, VITROS TDM PV III X6157 RESULT OF 19.9 UG/ML VS. THE EXPECTED RESULT OF 26.60 UG/ML. VITROS PHYT SLIDE LOT 2615-0166-7390, VITROS TDM PV III X6157 RESULTS OF 33.7, 34.4, 32.7, AND 32.3 UG/ML VS. THE EXPECTED RESULT OF 26.60 UG/ML. VITROS PHYT SLIDE LOT 2615-0166-9043, VITROS TDM PV III X6157 RESULT OF 19.8 UG/ML VS. THE EXPECTED RESULT OF 26.60 UG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WAS NO ALLEGATION OF PATIENT HARM. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT IS NUMBER 4 OF 6 MDR?S FOR THIS EVENT. SIX (6) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 6 DEVICES WERE INVOLVED. (B)(4)