ALERE AFINION AS100 ANALYZER

Description of Event or Problem

ON (B)(6) 2025 THE CUSTOMER EMAILED THEIR ACCOUNT MANAGER (AM) REPORTING THAT THEY WERE GOING TO CLOSE THE LID, IT SPARKED AND SINCE THEN IT HAS BEEN COMPLETELY BLACK. THE CUSTOMER CONFIRMED THE SERIAL NUMBER WAS (B)(6). THE CUSTOMER ALSO CONFIRMED THE INSTRUMENT WILL NOT SWITCH ON. ON (B)(6)2025 THE CUSTOMER ALSO CONFIRMED THE FOLLOWING: POWER SUPPLY FRA042-F24-8. THE SPARK WAS SIMILAR TO ELECTRIC STATIC DISCHARGE. THE INSTRUMENT IS LOCATED IN A SUITABLE ENVIRONMENT. THE CIRCUIT BREAKER TRIPPED AND INSTRUMENT WILL NOT POWER ON. NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. NO INJURIES WERE REPORTED.

Additional Manufacturer Narrative

DEVICE REPLACEMENT HAS BEEN INITIATED.

Description of Event or Problem

ON 10 FEB 2025 THE CUSTOMER EMAILED THEIR ACCOUNT MANAGER (AM) REPORTING THAT WHEN THEY WERE GOING TO CLOSE THE LID OF THE AFINION AS100 ANALYZER, IT SPARKED AND SINCE THEN IT HAS BEEN COMPLETELY BLACK. THE CUSTOMER CONFIRMED THE SERIAL NUMBER WAS (B)(6). THE CUSTOMER ALSO CONFIRMED THE INSTRUMENT WILL NOT SWITCH ON. ON 11 FEB 2025 THE CUSTOMER ALSO CONFIRMED THE FOLLOWING: POWER SUPPLY FRA042-F24-8. THE SPARK WAS SIMILAR TO ELECTRIC STATIC DISCHARGE. THE INSTRUMENT IS LOCATED IN A SUITABLE ENVIRONMENT. THE CIRCUIT BREAKER TRIPPED AND INSTRUMENT WILL NOT POWER ON. NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. NO INJURIES WERE REPORTED.

Additional Manufacturer Narrative

THE AFINION USER MANUAL STATES TO PLACE YOUR ALERE AFINION AS100 ANALYZER ON A DRY, CLEAN, STABLE AND HORIZONTAL SURFACE. MAKE SURE THAT THE ANALYZER IS LOCATED WITH SUFFICIENT SURROUNDING AIRSPACE, AT LEAST 5 INCHES ON EACH SIDE. ACCLIMATE THE ANALYZER TO AMBIENT OPERATING TEMPERATURE (15-32°C, 59-89°F). THE ANALYZER MIGHT BE IMPAIRED BY: ¿ CONDENSING HUMIDITY AND WATER. ¿ HEAT AND LARGE TEMPERATURE VARIATIONS. ¿ DIRECT SUNLIGHT. ¿ VIBRATIONS (E.G. FROM CENTRIFUGES AND DISHWASHERS). ¿ ELECTROMAGNETIC RADIATION. ¿ MOVEMENT OF THE ANALYZER DURING PROCESSING OF A TEST CARTRIDGE. WHEN CONNECTING THE POWER SUPPLY, THE FOLLOWING STEPS SHOULD BE FOLLOWED IN ORDER: - CONNECT THE POWER CABLE TO THE POWER CORD ADAPTER. - INSERT THE PLUG FROM THE POWER CORD ADAPTER INTO THE POWER SOCKET (FIGURE 3) IN THE BACK OF THE ANALYZER. - PLUG IN THE POWER CORD TO A WALL OUTLET. ONLY USE THE POWER SUPPLY AND CABLE SUPPLIED WITH ALERE AFINION AS100 ANALYZER. ANY OTHER POWER SUPPLIES OR CABLES CAN DAMAGE THE ANALYZER AND MAY CAUSE POSSIBLE HAZARDS. THE COMPLAINT INVESTIGATION IDENTIFIED THE MOST LIKELY CAUSE WAS THE POWER SUPPLY CORD, AS THIS WAS THE POWER SUPPLY CORD RECALLED IN 2020. THE COMPLAINT DETAILS WERE REVIEWED ALONG WITH OUR INTERNAL RECORDS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED IN THE COMPLAINT. THERE IS NO INDICATION THAT THE REPORTED ISSUE IS RELATED TO PRODUCT RESULTS, INADEQUATE INSTRUCTIONS FOR USE OR INACCURATE LABELING. CUSTOMER COMPLAINTS WILL CONTINUE TO BE MONITORED TO ENSURE CONTROL LIMITS ARE NOT EXCEEDED AND ENSURE THAT PRODUCT PERFORMANCE MEETS CUSTOMER EXPECTATIONS.