I-STAT1 ANALYZER, IMMUNO READY

Description of Event or Problem

NA.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6), EQUIPPED WITH AN I-STAT RECHARGEABLE BATTERY WITH A BORN-ON DATE (BOD) OF (B)(6) 2022 BECAME HOT TO THE TOUCH. FAILURE ANALYSIS DID NOT REPRODUCE THE COMPLAINT OF THE ANALYZER BECOMING HOT TO TOUCH. THE CUSTOMER ALSO REPORTS THAT THE POWER SCREEN BRIEFLY TURNS ON BEFORE SHUTTING OFF. WHICH WAS CAUSED AS A SHORT CIRCUIT ON THE MAIN BOARD (VBATT AND VBB CIRCUIT). THIS SHORT CIRCUIT CAUSED COMPONENTS U2 AND U51 ON THE MAIN BOARD TO FAIL, WHICH SUBSEQUENTLY CAUSED MULTIPLE COMPONENT FAILURES, INCLUDING L5, U1, U4, U7, AND U33 WITHIN THE ANALYZER. THE COMPONENTS U2 AND U51 AND OTHER FAILED AS A RESULT ARE NOT ASSOCIATED WITH HOT TO TOUCH.

Description of Event or Problem

ON (B)(6) 2025, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER (B)(6) BECAME HOT TO THE TOUCH. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. ANALYZER (B)(6) IS BEING REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THERE ARE NO INJURIES ASSOCIATED WITH THE EVENTS. HOWEVER, THE CUSTOMER STATES THE ANALYZER WAS USING A RECHARGEABLE BATTERY. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

Additional Manufacturer Narrative

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