I-STAT CREATININE CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-APR-2024. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF (B)(4) REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A23354.

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 27-MAR-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 40 YEAR OLD MALE PATIENT WITH POST PARTUM CARDIOMYOPSY, & SEPSIS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE LAB (B)(6) 2024 10:02 11:27 2.5 MMOL/L A LAB (B)(6) 2024 10:02 11:27 2.6 MMOL/L A I-STAT (B)(6) 2024 10:02 10:38 3.6 MMOL/L A AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. NO REPORTS OF DELAY OR IMPACT TO PATIENT MANAGEMENT. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY.