I-STAT RECHARGEABLE POWER PACK

Description of Event or Problem

ON 09-NOV-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT TWO RECHARGEABLE BATTERY ((B)(6)) BECAME HOT TO TOUCH WHEN INSTALLED IN ANALYZERS. 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). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 01-FEB-2024. THE CUSTOMER REPORTED THAT TWO I-STAT RECHARGEABLE POWER PACKS, EACH WITH A BORN-ON DATE OF (B)(6) 2023, WERE HOT TO TOUCH WHEN PLACED IN TWO I-STAT 1 ANALYZERS S/N (B)(6) AND S/N (B)(6). THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE COMPLAINT AS THE RECHARGEABLE POWER PACKS HAVE 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.