I-STAT CREA CARTRIDGE

Description of Event or Problem

ON 29-MAR-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 75 YEAR OLD MALE PATIENT PRESENTED FOR A 6 MONTH CANCER FOLLOW UP. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). 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). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

NA.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 19-APR-2023. THE CUSTOMER REPORTED UNEXPECTED HIGH CREATININE RESULTS WHEN COMPARING THE I-STAT ANALYZER TO THE RESULT FROM A LAB ANALYZER. AN MDR WAS FILED ON 11-APR-2023 BASED ON THE DATA AVAILABLE AT THE TIME. ON 12-APR-2023, THE CUSTOMER EMAILED TO CONFIRM THAT THE PATIENT'S ONCOLOGIST VERIFIED PATIENT TO BE ON HYDROXYUREA. THE INVESTIGATION FOR THIS INCIDENT WAS OPENED ON 18-APR-2023. AS PER ARTWORK 765791-00 REV. B REV. DATE 06-MAR-2020, I-STAT CREA CARTRIDGE, HYDROXYUREA IS A KNOWN INTERFERENT WHERE THE I-STAT CREATININE RESULTS WILL BE INCREASED. THE RECOMMENDATION IS TO USE ANOTHER METHOD. PRODUCT FUNCTIONING ACCORDING TO SPECIFICATION AND DIRECTION.