I-STAT CREATININE CARTRIDGE

Description of Event or Problem

ON 27-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 50 YEAR OLD MALE PATIENT WITH A NON HEALING SURGICAL WOUND. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED RESULT (MG/DL) SAMPLE I-STAT (B)(6) 2022 1307 1309 >2.0 WB BECKMAN NI. 1.8 NI THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 16-DEC-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 Q04.01.003 REV. AN, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A24253.