I-STAT RECHARGEABLE POWER PACK

Additional Manufacturer Narrative

APOC INCIDENT # 929877. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A RECHARGEABLE BATTERY (B)(6) BECAME HOT TO TOUCH WHEN IT WAS REMOVED FROM THE ANALYZER THAT WAS GENERATING A QUALITY CHECK CODE 86. CUSTOMER STATES THAT THEY REPLACED THE BATTERY WITH A KNOWN WORKING BATTERY AND CODE 86 RESOLVED AND ANALYZER IS FUNCTIONING NORMALLY AT THIS TIME. CUSTOMER REPORTS NO DAMAGE TO I-STAT 1 WIRELESS ANALYZER OR TO THE I-STAT 1 DOWNLOADER RECHARGER IT WAS DOCKED IN. THE RECHARGEABLE BATTERY WAS 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. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. 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.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 14-NOV-2023. THE CUSTOMER REPORTED THAT A I-STAT RECHARGEABLE POWER PACK, WITH A BORN-ON DATE OF 2016-08, WAS HOT TO TOUCH AND DEFORMED WHEN REMOVED FROM ANALYZER S/N (B)(6). CUSTOMER ALSO REPORTED ANALYZER S/N (B)(6) IS FUNCTIONING AS EXPECTED WITH ANOTHER RECHARGEABLE BATTERY. THE CUSTOMER COMPLAINT WAS CONFIRMED VIA THE PHOTO PROVIDED. HOWEVER, WITHOUT RETURN OF THE BATTERY THAT WAS IN USE, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE COMPLAINT. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.