I-STAT1 ANALYZER, IMMUNO READY

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). OTHER PRODUCT RETURNING FOR INVESTIGATION: PRODUCT# 04P73-04. DESCRIPTION: I-STAT1 DOWNLOADER RECHARGER. SERIAL#: (B)(6). MFG DATE: 15-APR-2024. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

ON 15-NOV-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER (B)(6) WAS EMITTING A SMOKING SMELL AND FELT WARM TO THE TOUCH. THE CHARGING PINS ON THE ANALYZER WERE CHARRED. THE INCIDENT OCCURRED WHILE THE ANALYZER WAS IN THE I-STAT1 DOWNLOADER RECHARGER (DRC-137758), WHICH ALSO SHOWED CHAR DAMAGE NEAR THE CHARGING PINS. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. ANALYZER (B)(6) AND DOWNLOADER RECHARGER DRC-137758 ARE 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.

Description of Event or Problem

NA.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 21-JAN-2025. ANALYZER S/N (B)(6): THE CONCLUSION OF THE INVESTIGATION IS THAT THE CUSTOMER'S COMPLAINTS WERE CONFIRMED. ALTHOUGH THE BURNT SMELL AND THE WARM TO TOUCH CONDITION OBSERVED BY THE CUSTOMER WERE NOT REPRODUCED, IT WAS DETERMINED THAT THE CORROSION FOUND ON THE ANALYZER RECHARGE CONTACT PINS CAUSING AN ELECTRICAL SHORT AND LED TO "SPARKS" APPEARED WHEN ANALYZER S/N (B)(6) WAS DOCKED IN DRC S/N (B)(6) AT THE CUSTOMER SITE. THIS GAVE THE RECHARGE CONTACT PINS TO HAVE BURNT APPEARANCE AND RESULTED IN A BURNING SMELL THAT EMANATED FROM THE ANALYZER. FURTHERMORE, IT SHOULD BE NOTED THAT DRC S/N (B)(6) THAT WAS ASSOCIATED WITH INCIDENT (B)(4) WAS NOT RETURNED FOR EVALUATION, AND IT CANNOT BE RULED OUT AS HAVING CAUSED OR CONTRIBUTED TO THE COMPLAINT. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED. DRC S/N (B)(6): FAILURE ANALYSIS COULD NOT BE PERFORMED AS DRC S/N (B)(6) 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.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2025. THE CUSTOMER REPORTED THAT, WHEN ANALYZER S/N (B)(6) (CONTAINING A RECHARGEABLE BATTERY WITH A BORN-ON DATE (BOD) OF (B)(6) 2023) WAS DOCKED IN DOWNLOADER RECHARGER (DRC) S/N (B)(6), A SMOKY SMELL WAS EMANATING FROM THE ANALYZER. THE ANALYZER WAS WARM TO TOUCH, AND THE RECHARGE CONTACT PINS ON THE BACK OF THE ANALYZER WERE CHARRED. THE CUSTOMER ALSO MENTIONED THAT CHARRED DAMAGE WAS NOTED NEAR THE RECHARGE CONTACT PINS OF THE DRC. ANALYZER S/N (B)(6): THE CONCLUSION OF THE INVESTIGATION IS THAT THE CUSTOMER'S COMPLAINTS WERE CONFIRMED. ALTHOUGH THE BURNT SMELL AND THE WARM TO TOUCH CONDITION OBSERVED BY THE CUSTOMER WERE NOT REPRODUCED, IT WAS DETERMINED THAT THE CORROSION FOUND ON THE ANALYZER RECHARGE CONTACT PINS CAUSING AN ELECTRICAL SHORT AND LED TO "SPARKS" APPEARED WHEN ANALYZER S/N (B)(6) WAS DOCKED IN DRC S/N (B)(6) AT THE CUSTOMER SITE. THIS GAVE THE RECHARGE CONTACT PINS TO HAVE BURNT APPEARANCE AND RESULTED IN A BURNING SMELL THAT EMANATED FROM THE ANALYZER. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED. DRC S/N (B)(6): THE CUSTOMER'S COMPLAINT WAS CONFIRMED UPON VISUAL EXAMINATION OF DRC S/N (B)(6): SCORCH MARKS WERE NOTED ON THE SURFACE OF THE FRONT COVER RIGHT ABOVE THE RECHARGE CONTACT PINS, AND THE RECHARGE CONTACT PINS WERE CHARRED UPON RECEIPT. THE COSMETIC DAMAGE OBSERVED ON THE COMPLAINT DRC WAS CAUSED BY CORROSION ON ANALYZER S/N (B)(6) RECHARGE CONTACT PINS, WHICH LED TO AN ELECTRICAL SHORT AND RESULTED IN SPARKS APPEARING (FORMATION OF THE SCORCH MARKS ON THE FRONT COVER AND CHARRED PINS) WHEN THE ANALYZER WAS DOCKED IN DRC S/N (B)(6) AT THE CUSTOMER SITE. 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.