I-STAT CREATININE CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09-NOV-2023. AN MDR WAS FILED ON 31-OCT-2023 BASED ON THE DATA AVAILABLE AT THE TIME. ON 06-NOV-2023, THE CUSTOMER EMAILED WITH THE PATIENT'S MEDICATION LIST WHICH INCLUDED HYDROXYUREA (LISTED AS HYDREA OR HYDROXYCARBAMIDE). THE INVESTIGATION FOR THIS INCIDENT WAS OPENED ON 06-NOV-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. H06: TYPE OF INVESTIGATION: NO TESTING PERFORMED.

Description of Event or Problem

ON (B)(6) 2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD RESULTS SAMPLE I-STAT 273 MOL/L BE IV CITRATHEPARIN. I-STAT 265 MOL/L BE CAPILLARY WITHOUT ADDITIVES. LAB HELIOS 118 MOL/L MEASUREMENT FROM PLASMA (HEPARIN). LAB HELIOS 116 MOL/L REPEAT MEASUREMENT FROM THE SAME BE (PLASMA WAS FROZEN, FOR POSSIBLE FOLLOW-UP MEASUREMENTS). CUSTOMER DID NOT PROVIDE TEST/COLLECTION TIMES, DATES, NOR DETAILS SURROUND THE EVENT. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. TWO I-STAT RESULTS ARE CONSISTENTLY HIGH ON TWO DIFFERENT SAMPLES. IT IS SUSPECTED BASED ON THE ELEVATED I-STAT RESULTS THAT THE PATIENT MAY BE ON HYDROXYUREA AND THE CAUSE FOR THE ELEVATED RESULTS. HOWEVER, THERE WAS NO CONFIRMATION OF THE PATIENT'S MEDICATIONS AT THE TIME OF THIS REPORT. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

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