I-STAT BNP CARTRIDGE

Description of Event or Problem

ON 03-MAY-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT BNP CARTRIDGES THAT YIELDED A FALSE POSITIVE ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED BNP I-STAT (B)(6) 2024 11:38 938 NG/L LAB (B)(6) 2024 NI 488 NG/L AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 716969-00N THE I-STAT BNP TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUANTITATIVE MEASUREMENT OF B-TYPE NATRIURETIC PEPTIDE (BNP) IN WHOLE BLOOD OR PLASMA SAMPLES USING EDTA AS THE ANTICOAGULANT. BNP MEASUREMENTS CAN BE USED AS AN AID IN THE DIAGNOSIS AND ASSESSMENT OF THE SEVERITY OF CONGESTIVE HEART FAILURE.

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 03-JUL-2024. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR BNP CARTRIDGE LOT B24040.