I-STAT CHEM8+ CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 14-APR-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AP, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, EXCEPT FOR THE RATE OF IONIZED CALCIUM RESULTS OUTSIDE OF THE TOTAL ALLOWABLE ERROR WHEN TESTING IS PERFORMED USING WHOLE BLOOD (WB). A PREVIOUSLY IDENTIFIED DEFICIENCY FOR ICA RESULTS OUTSIDE OF EA, WHICH IS UNRELATED TO THE CUSTOMER'S OBSERVATION OF NA AND CREA DISCREPANT RESULTS, HAS BEEN DETERMINED FOR CHEM8+ CARTRIDGE LOT H25310 AND IS UNDER INVESTIGATION IN QUALITY RECORD 1096422.

Description of Event or Problem

NA.

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) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGE THAT YIELDED A DISCREPANT SODIUM RESULT ON A 25-YEAR-OLD MALE PATIENT WITH RIGHT-SIDED WEAKNESS, FACIAL DROOP. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE RESULT I-STAT (B)(6) 2026 166 LAB (B)(6) 2026 138 I-STAT (B)(6) 2026 140. 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.