AFINION 2, NOR

Description of Event or Problem

ON 25-SEP-2024 THE DISTRIBUTOR CALLED ACCOUNT MANAGER (AM), REPORTING ON BEHALF OF A CUSTOMER THAT THEY HAD AN ISSUE WITH THEIR AFINION 2 INSTRUMENT. ON 26-SEP-2024, AM CALLED THE CUSTOMER WHO REPORTED THAT THEIR AFINION 2 INSTRUMENT FOR ADDITIONAL INFORMATION. SERIAL NO. (B)(6), TURNED BLACK AND THEY HEARD A BANG SOUND WHEN THEY PRESSED THE DISPLAY TO REMOVE A CRP TEST CASSETTE (DETAILS NOT PROVIDED). THE USER OF THE INSTRUMENT FELT A SMALL ELECTRICAL SHOCK AFTER A WHILE, THE INSTRUMENT AND SCREEN WAS TURNED ON BY ITSELF AGAIN AND THE USER OF THE INSTRUMENT TRIED ONE MORE TIME TO USE THE INSTRUMENT, BUT THE SAME ISSUE OCCURRED AGAIN. CUSTOMER THEN REMOVED THE POWER SUPPLY AND DID NOT USE THE INSTRUMENT ANYMORE. ON 26-SEP-2024 TECHNICAL SERVICE (TS) RECEIVED EMAIL FROM AM REPORTING THE ABOVE EVENT AND CALLED THE CUSTOMER. THE CUSTOMER CONFIRMED THE INSTRUMENT WAS IN A SUITABLE ENVIRONMENT, AND THEY FELT A LITTLE SHORT ELECTRICAL SHOCK - ONLY IN THEIR HAND - WHEN TOUCHING THE INSTRUMENT SCREEN. THERE WAS NO SHOCK FROM THE POWER SUPPLY OR MAINS CORD. THE POWER CORD BEING USED WAS BLACK WITH SERIAL NUMBER: MODELL (B)(6). CUSTOMER CONFIRMED THERE WAS NO INJURY, THE SHOCK DID NOT CAUSE PAIN IN THEIR HAND.

Additional Manufacturer Narrative

FINDINGS FROM THE INTERNAL INVESTIGATION COULD NOT IDENTIFY THE CAUSE OF THE ELECTRICAL SHOCK, AS BOTH THE INSTRUMENT AND POWER SUPPLY PASSED THE OVERALL INSPECTION OF THE RETURNED PRODUCTS. THE USER MANUAL EXPLAINS TO PLACE YOUR AFINION 2 ANALYZER ON A DRY, CLEAN, STABLE AND HORIZONTAL SURFACE. MAKE SURE THAT THE ANALYZER IS LOCATED WITH SUFFICIENT SURROUNDING AIRSPACE, AT LEAST 10 CM ON EACH SIDE. PLACEMENT OF AFINION 2 ANALYZER SHOULD ALLOW EASY DISCONNECTION FROM THE WALL OUTLET AT ANY TIME. ACCLIMATE THE ANALYZER TO AMBIENT OPERATING TEMPERATURE BEFORE USE (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. ACCORDING TO THE USER MANUAL, 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 AFINION 2. ANY OTHER POWER SUPPLIES OR CABLES CAN DAMAGE THE ANALYZER AND MAY CAUSE POSSIBLE HAZARDS. THE COMPLAINT DETAILS WERE REVIEWED ALONG WITH INTERNAL RECORDS AND NO NONCONFORMANCES WERE IDENTIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED IN THE COMPLAINT. THE RISKS SHOW THAT THE EVENT IS CORRESPONDING WITH WHAT IS ANTICIPATED FOR THE NATURE AND SEVERITY OF THE PRODUCT. THE EVENT DOES NOT REPRESENT ANY NEW OR UNANTICIPATED FAILURE MODE OR HAZARD/HARM COMBINATION. OUR INVESTIGATION DETERMINED THAT 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 PRODUCT'S PERFORMANCE MEETS CUSTOMERS' EXPECTATIONS.

Description of Event or Problem

ON (B)(6)2024 THE DISTRIBUTOR CALLED ACCOUNT MANAGER (AM), REPORTING ON BEHALF OF A CUSTOMER THAT THEY HAD AN ISSUE WITH THEIR AFINION 2 INSTRUMENT. ON (B)(6)2024, AM CALLED THE CUSTOMER WHO REPORTED THAT THEIR AFINION 2 INSTRUMENT FOR ADDITIONAL INFORMATION. SERIAL NO. (B)(6), TURNED BLACK AND THEY HEARD A BANG SOUND WHEN THEY PRESSED THE DISPLAY TO REMOVE A CRP TEST CASSETTE (DETAILS NOT PROVIDED). THE USER OF THE INSTRUMENT FELT A SMALL ELECTRICAL SHOCK AFTER A WHILE, THE INSTRUMENT AND SCREEN WAS TURNED ON BY ITSELF AGAIN AND THE USER OF THE INSTRUMENT TRIED ONE MORE TIME TO USE THE INSTRUMENT, BUT THE SAME ISSUE OCCURRED AGAIN. CUSTOMER THEN REMOVED THE POWER SUPPLY AND DID NOT USE THE INSTRUMENT ANYMORE. ON 26-SEP-2024 TECHNICAL SERVICE (TS) RECEIVED EMAIL FROM AM REPORTING THE ABOVE EVENT AND CALLED THE CUSTOMER. THE CUSTOMER CONFIRMED THE INSTRUMENT WAS IN A SUITABLE ENVIRONMENT, AND THEY FELT A LITTLE SHORT ELECTRICAL SHOCK - ONLY IN THEIR HAND - WHEN TOUCHING THE INSTRUMENT SCREEN. THERE WAS NO SHOCK FROM THE POWER SUPPLY OR MAINS CORD. THE POWER CORD BEING USED WAS BLACK WITH SERIAL NUMBER: MODELL FRA042-S24-8, N14939, R30428204. CUSTOMER CONFIRMED THERE WAS NO INJURY, THE SHOCK DID NOT CAUSE PAIN IN THEIR HAND.