I-STAT CREATININE CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 16-DEC-2024. 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. RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERION FOR SUPPRESSED RESULTS BUT THE SAMPLE SIZE WAS TOO LOW (< 17) TO ASSESS POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A24201.

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 15-NOV-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 77-YEAR-OLD MALE PATIENT WITH TIA AND POLYCYTHEMIA VERA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD I-STAT DATE (B)(6) 2024 COLLECTED 14:46 TESTED 14:46 CREA (MG/DL) 2.4. METHOD I-STAT DATE (B)(6) 2024 COLLECTED NI TESTED NI CREA (MG/DL) NI. METHOD LAB DATE (B)(6) 2024 COLLECTED NI TESTED NI CREA (MG/DL) 0.9. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. CURRENTLY THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.