I-STAT1 ANALYZER, IMMUNO READY

Additional Manufacturer Narrative

APOC INCIDENT # 979198. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

ON 16-MAY-2025, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(6) WAS EMITTING SMOKE. 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. THE CUSTOMER WAS USING A RECHARGEABLE BATTERIES. 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 21-AUG-2025. THE CUSTOMER REPORTED THAT, WHEN ANALYZER S/N (B)(6) (CONTAINING AN I-STAT RECHARGEABLE BATTERY) WAS DOCKED IN A DOWNLOADER RECHARGER (DRC) S/N UNKNOWN, A POPPING SOUND WAS HEARD AND SMOKE WAS EMITTED FROM THE DRC. FAILURE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE DRC'S SERIAL NUMBER WAS NOT IDENTIFIED AND THE DRC HAS NOT BEEN 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.