I-STAT1 ANALYZER, IMMUNO READY

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) 20256, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(6) BECAME HOT TO THE TOUCH. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE PRODUCT 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

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 24-JUN-2026. THE CUSTOMER REPORTED REMOVING THE RECHARGEABLE POWER PACK, WITH A BORN ON DATE (BOD) OF (B)(6) 2024, FROM I STAT 1 ANALYZER S/N (B)(6) AFTER IT BECAME VERY HOT. THE CUSTOMER ALSO NOTED THAT ONLY THE RECHARGEABLE POWER PACK, AND NOT THE ANALYZER, WAS HOT TO THE TOUCH. ADDITIONALLY, THE CUSTOMER REPORTED THAT MULTIPLE PRESSES OF THE POWER BUTTON WERE REQUIRED FOR THE ANALYZER TO TURN ON. FAILURE ANALYSIS COULD NOT BE PERFORMED, AS ANALYZER S/N (B)(6) AND THE RECHARGEABLE POWER PACK WERE NOT RETURNED TO FLEX. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

Description of Event or Problem

NA.