I-STAT1 ANALYZER, IMMUNO READY

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 15-JAN-2026. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6), EQUIPPED WITH A RECHARGEABLE POWER PACK WITH A BORN-ON DATE (BOD) OF (B)(6) 2022 INSTALLED, OCCASIONALLY BECOMES HOT TO THE TOUCH AND TESTING IS DISABLED. THE ANALYZER WAS HOT WHEN REMOVED FROM THE I-STAT 1 DOWNLOADER RECHARGER (DRC). ALTHOUGH THE CUSTOMER REPLACED THE DRC, THE ISSUE PERSISTS. ADDITIONALLY, THE CUSTOMER ALSO MENTIONED THAT THE CABLES IN USE WERE ISSUED BY APOC. FAILURE ANALYSIS DID NOT CONFIRM THE REPORTED ISSUE, AND THE ANALYZER FUNCTIONED ACCORDING TO SPECIFICATION THROUGHOUT TESTING. 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.

Description of Event or Problem

ON 31-OCT-2025, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(6) BECAME HOT TO THE TOUCH. THE INCIDENT OCCURRED WHILE THE ANALYZER WAS IN THE I-STAT1 DOWNLOADER RECHARGER. THEY IMMEDIATELY TOOK ANALYZER OFF WHICH DISPLAYED ERROR 66 AND UNPLUGGED THE DOWNLOADER. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. ANALYZER SN (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

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