I-STAT1 ANALYZER, IMMUNO READY

Description of Event or Problem

NA.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 25-SEP-2024. THE CUSTOMER REPORTED THAT WIRELESS ANALYZER S/N (B)(6) GENERATED QUALITY CHECK CODE (QCC) 66, AND THE TEMPERATURE READING SHOWED DASHES (---) ON THE ANALYZER STATUS PAGE. THE CUSTOMER ADDED THAT THE WIRELESS ANALYZER (WITH RECHARGEABLE BATTERIES INSTALLED) WAS HOT TO TOUCH AND WOULD NOT CHARGE WHEN DOCKED IN DOWNLOADER RECHARGER (DRC) S/N (B)(6). ADDITIONALLY, THE CUSTOMER CONFIRMED THAT AN INCORRECT 24V POWER SUPPLY ADAPTER WAS USED WITH THE DRC. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE COMPLAINT WAS THE USE OF A 24 VDC POWER SUPPLY ADAPTER AT THE CUSTOMER SITE, WHICH IN TURN CAUSED COMPONENT FAILURE IN BOTH THE DRC AND THE WIRELESS ANALYZER. THIS CAUSED THE WIRELESS ANALYZER TO GENERATE QCC 66, TO BECOME HOT TO TOUCH, AND TO BE UNABLE TO CHARGE WHEN DOCKED IN THE DRC AS REPORTED BY THE CUSTOMER. AS PER THE I-STAT SYSTEM MANUAL [REF. (B)(4)], THE OUTPUT VOLTAGE OF THE POWER SUPPLY ADAPTER FOR THE DRC MUST NOT EXCEED 12 VDC. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

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) 2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(6) FELT HOT TO THE TOUCH NEAR BATTERY COMPARTMENT AND WILL NOT CHARGE. CUSTOMER STATES THEY ARE USING RECHARGEABLE BATTERIES. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. ANALYZER WILL BE REPLACED AT NO CHARGE AND RETURNED 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 PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.