I-STAT CG4+ CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 28-APR-2025. THE CUSTOMER REPORTED OBTAINING A DISCREPANCY IN POTENTIAL OF HYDROGEN (PH), PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2), PARTIAL PRESSURE OF OXYGEN (PO2), BASE EXCESS (BE), BICARBONATE (HC03) AND SATURATED OXYGEN (SO2) PATIENT SAMPLE RESULTS BETWEEN TESTING PERFORMED USING CG4+ CARTRIDGE LOT M25009 AND A COBAS LAB INSTRUMENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AN, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR CG4+ CARTRIDGE LOT M25009.

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 09-APR-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A 55 YEAR OLD MALE PATIENT WITH ACUTE LIVER FAILURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE: COLLECTED TESTED PH PCO2 PO2 BEECF HC03 SO2. SAMPLE: I-STAT (B)(6) 2025 UNK 17:21 6.604 39.4 MMHG 39 MMHG <-30 MMHG 3.9 MMOL/L 25% A. COBAS (B)(6) 2025 18:01 18:01 7.364 20.9 MMHG 37.1 MMHG -12.5 MMHG 11.6 MMOL/L 52.5% B. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.