I-STAT BNP CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 12/16/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AD (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR BNP CARTRIDGE LOT D19171.

Description of Event or Problem

NA.

Additional Manufacturer Narrative

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

Description of Event or Problem

ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT BNP CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT BNP RESULT OF 63 ON A (B)(6) YEAR OLD MALE PATIENT PRESENTED WITH FLUID OVERLOAD. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: 10/20/2019, COLLECTED: 05:30, TESTED: 06:06, RESULT: 63 PG/ML, SAMPLE: A. I-STAT, 10/20/2019, NI, 08:50, 834 PG/ML, B. I-STAT, 10/20/2019, 05:30, 09:01, 813 PG/ML, A. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.