VITROS IMMUNODIAGNOSTIC PRODUCTS BRAHMS PCT REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS IMMUNODIAGNOSTICS PRODUCTS B¿R¿A¿H¿M¿S PCT REAGENT PACK (PCT) RESULTS WERE OBTAINED FROM 10 DIFFERENT PATIENT SAMPLES AND 2 DIFFERENT LEVELS OF VITROS PCT LOT 0320 CONTROLS TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULTS WAS A REAGENT PACK RELATED ISSUE. THE AFFECTED RESULTS WERE ISOLATED TO A SINGLE REAGENT PACK. THE ISSUE WITH THE AFFECTED REAGENT PACK IS UNKNOWN, AS IT IS ASSUMED THE AFFECTED REAGENT PACK WAS DISCARDED BY THE CUSTOMER AND NO FURTHER INVESTIGATION WAS POSSIBLE. EXCEPT FOR THE AFFECTED REAGENT PACK, THERE WAS NO INDICATION THAT VITROS PCT REAGENT LOT 0350 WAS NOT PERFORMING AS INTENDED, BASED ON HISTORICAL QUALITY CONTROL RESULTS. IN ADDITION, THERE IS NO INDICATION THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM MALFUNCTIONED AS ACCEPTABLE VITROS PCT PERFORMANCE WAS OBTAINED USING ALTERNATE VITROS PCT LOT 0350 REAGENT PACKS PRIOR TO, AND AFTER THE EVENT. THE EVENT IS ISOLATED TO REAGENT PACK ID (B)(6).

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IMMUNODIAGNOSTICS PRODUCTS B¿R¿A¿H¿M¿S PCT REAGENT PACK (PCT) RESULTS WERE OBTAINED FROM 10 DIFFERENT PATIENT SAMPLES AND 2 DIFFERENT LEVELS OF VITROS PCT LOT 0320 CONTROLS TESTED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE 1 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 8.76 NG/ML PATIENT SAMPLE 2 VITROS PCT RESULT OF 0.226 NG/ML VS. THE EXPECTED RESULT OF 2.25 NG/ML PATIENT SAMPLE 3 VITROS PCT RESULT OF 0.062 NG/ML VS. THE EXPECTED RESULT OF 9.28 NG/ML PATIENT SAMPLE 5 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 5.59 NG/ML PATIENT SAMPLE 6 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 1.22 NG/ML PATIENT SAMPLE 7 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 3.14 NG/ML PATIENT SAMPLE 9 VITROS PCT RESULT OF 0.037 NG/ML VS. THE EXPECTED RESULT OF 4.31 NG/ML PATIENT SAMPLE 12 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 3.77 NG/ML PATIENT SAMPLE 13 VITROS PCT RESULT OF <0.030 NG/ML VS. THE EXPECTED RESULT OF 12.8 NG/ML PATIENT SAMPLE 14 VITROS PCT RESULT OF 0.100 NG/ML VS. THE EXPECTED RESULT OF 0.61 NG/ML VITROS PCT CONTROL LOT 0320 LEVEL 1 RESULTS OF <0.03, <0.03 AND <0.03 PG/ML VS. THE EXPECTED RESULT OF 0.40 PG/ML VITROS PCT CONTROL LOT 0320 LEVEL 3 RESULTS OF <0.03, <0.03 AND <0.03 PG/ML VS. THE EXPECTED RESULT OF 52.0 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS PCT PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, CORRECTED REPORTS WERE ISSUED. NO TREATMENT WAS STARTED, STOPPED OR ALTERED BASED ON THE LOWER THAN EXPECTED VITROS PCT RESULTS REPORTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).