I-STAT CHEM8+ CARTRIDGE

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 (B)(6) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED DISCREPANT POTASSIUM RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION, TEST/COLLECTION TIMES, NOR DETAILS SURROUNDING THE EVENT AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD CREA I-STAT 761 UMOL/L. LAB 90 UMOL/L. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 04-JUN-2024. THE CUSTOMER REPORTED UNEXPECTED HIGH CREATININE RESULTS ON AN UNKNOWN CHEM8+ CARTRIDGE LOT (LATER DETERMINED TO BE LOT H24003) WHEN COMPARING THE I-STAT ANALYZER RESULTS TO THE RESULTS ON A ROCHE COBAS 8000 LAB ANALYZER. AN MDR WAS FILED ON (B)(6) 2024 BASED ON THE DATA AVAILABLE AT THE TIME. THE INCIDENT WAS RAISED TO A LEVEL 2 COMPLAINT ON (B)(6) 2024. ON (B)(6) 2024, THE CUSTOMER EMAILED MORE INFORMATION WHICH INCLUDED THAT THE PATIENT WAS ON HYDROXYUREA AT THE TIME OF THE TESTING. AS PER ARTWORK 765874-00 REV. D REV. DATE (B)(6) 2021, I-STAT CHEM8+ CARTRIDGE, HYDROXYUREA IS A KNOWN INTERFERENT WHERE THE I-STAT CREATININE RESULTS WILL BE INCREASED.