ARCHITECT BNP REAGENT KIT

Additional Manufacturer Narrative

UPON FURTHER REVIEW, IT WAS IDENTIFIED THE INCIDENT WAS PREVIOUSLY SUBMITTED WITH THE INCORRECT MANUFACTURING SITE, ABBOTT LABORATORIES, 100 ABBOTT PARK ROAD, ABBOTT PARK, IL 60064, UNDER THE MFR REPORT #, 1415939-2023-00037. ALL THE INFORMATION FROM 1415939-2023-00037 IS INCLUDED IN THIS SUBMISSION WHICH CORRECTS THE MANUFACTURER INFORMATION IN SECTION D AND G AS WELL AS THE MFR REPORT #. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 46257FP00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, DEVIATIONS, OR POTENTIAL NON-CONFORMANCES. ACCURACY TESTING WAS PERFORMED TO EVALUATE THE PERFORMANCE WITH REAGENT LOT 46257FP00. AN INTERNAL ARCHITECT BNP PANEL SET WAS TESTED WITH RETAINED KITS OF THE COMPLAINT LOT ON THREE INSTRUMENTS. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT BNP REAGENT LOT 46257FP00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT BNP RESULTS FOR ONE 41-YEAR-OLD MALE PATIENT PRESENTING WITH A COUGH FOR 10 DAYS AND FEVER AND CHEST TIGHTNESS FOR THREE DAYS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0-100 PG/ML): ON (B)(6) 2023, SID UNKNOWN BNP AT 10:35 WAS 151.8 PG/ML, BLOOD WAS DRAWN AGAIN THAT EVENING AT 23:39 AND THE BNP RESULT WAS 403.60 PG/ML. OTHER TESTING PERFORMED: THE TROPONIN RESULT WAS 17 NG/ML AND THE EKG SHOWED AN ABNORMALITY. OVERNIGHT THE PATIENT¿S CONDITION WORSENED, HE WAS COUGHING UP PINK FOAMY SPUTUM WHEN SITTING UP AND BREATHING AND IT WAS CONSIDERED TO BE A SEVERE CASE OF MYOCARDITIS. THE BNP RESULT IN THE MORNING WAS ONLY 151.8 PG/ML, BUT THE THRESHOLD VALUE FOR CLINICAL DIAGNOSIS WAS 300 PG/ML, THUS THE CUSTOMER STATED THAT MEDICATION WAS NOT ADMINISTERED IN A TIMELY MANNER (TYPE OF MEDICATION UNKNOWN) DUE TO THE DEPRESSED ARCHITECT BNP RESULT. NEW INFORMATION ADDED TO THE TICKET ON (B)(6) 2023. THE FINAL DIAGNOSES OF THE PATIENT WAS SEVERE PNEUMONIA AND HEART FAILURE.