ALERE AFINION AS100 ANALYZER

Additional Manufacturer Narrative

THE INSTRUMENT WAS NOT RECEIVED BY THE LEGAL MANUFACTURER FOR FURTHER INVESTIGATION, THUS THE MOST PROBABLE CAUSE RELATED TO THE SPARK EVENT COULD NOT BE DETERMINED THIS CASE. 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 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. FURTHERMORE, CARTRIDGE HANDLING INSTRUCTIONS ARE INCLUDED FOR INSPECTING THE TEST CARTRIDGE. THE CARTRIDGE IS NOT TO BE USED IF THE FOIL POUCH PACKAGING, THE DESICCANT BAG OR THE TEST CARTRIDGE ITSELF IS DAMAGED OR IF DESICCANT PARTICLES ARE FOUND ON THE CARTRIDGE. THE USER MANUAL PROVIDES INSTRUCTIONS ON HOW TO INSERT THE CARTRIDGE AND STATES THAT USER SHOULD MAKE SURE THAT THE TEST CARTRIDGE IS CORRECTLY PLACED IN THE CARTRIDGE CHAMBER. THE USER MANUAL ALSO GUIDES THE USER ON HOW TO REMOVE A CARTRIDGE AND IF THE TEST CARTRIDGE IS NOT EJECTED, TO RESTART THE ANALYZER. THE LID PROTECTS THE CARTRIDGE CHAMBER FROM DUST, DIRT, LIGHT AND HUMIDITY DURING PROCESSING AND WHEN THE ANALYZER IS NOT IN USE. LID ISSUES ARE TYPICALLY ASSOCIATED WITH WEAR AND TEAR AND REQUIRE REPLACEMENT OF LID SPRINGS, LID SENSORS OR LID ADJUSTMENTS. IF THE ISSUE PERSISTS, THE ANALYZER NEEDS TO BE RETURNED AND REPLACED. IT SHOULD BE NOTED THAT THE USER MANUAL PROVIDES INSTRUCTIONS ON HOW TO HANDLE THE LID CAREFULLY, THAT THE LID MUST BE MANUALLY CLOSED BUT OPENS AUTOMATICALLY AND FURTHER CLARIFIES NOT TO OPEN THE LID MANUALLY. THE ANALYZER IS DESIGNED WITH A NUMBER OF FAILSAFE MECHANISMS WHICH WILL ABORT THE TEST AND DISPLAY INFORMATION CODE 302 IF THE ANALYZER IS NOT ABLE TO PROPERLY COMPLETE THE TEST. IF THE INFORMATION CODE 302 PERSISTS AFTER TROUBLESHOOTING, THE ANALYZER NEEDS TO BE RETURNED AND REPLACED. IT SHOULD BE NOTED THAT THE USER MANUAL PROVIDES INSTRUCTIONS IN THE "INFORMATION CODES AND TROUBLESHOOTING" SECTION ON WHAT ACTIONS SHOULD BE TAKEN BY THE USERS WHEN DEALING WITH THIS ANALYZER FAILURE: ¿RESTART THE ANALYZER AND RUN CONTROLS. REPEAT THE TEST WITH A NEW SAMPLE AND TEST CARTRIDGE¿. 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.

Description of Event or Problem

05-AUG-2024 THE CUSTOMER CONTACTED TECHNICAL SERVICES (TS) BY PHONE REPORTING THEIR AFINION (B)(6) WITH CONTINUOUS 302 INFO CODES. THE CUSTOMER ALSO REPORTED THAT THE LID DOES NOT OPEN PROPERLY ANYMORE AND THAT THEY USED SCISSORS TO HELP OPENING THE INSTRUMENT. WHEN THEY PLUGGED THE INSTRUMENT OUT AND BACK INTO THE SOCKET DURING THE CALL THERE WAS AN ELECTRIC DISCHARGE/SPARK. THE CUSTOMER CONFIRMED THAT THIS DID NOT TOUCH HER AND THAT SHE WAS UNHARMED. 12-AUG-2024 CUSTOMER CONFIRMED SPARK WAS OCCURRED WHEN CABLE WAS PLUGGED INTO BACK OF THE INSTRUMENT.

Description of Event or Problem

05-AUG-2024 THE CUSTOMER CONTACTED TECHINCAL SERVICES (TS) BY PHONE REPORTING THEIR AFINION 9613069-2024-00003 WITH CONTINUOUS 302 INFO CODES. THE CUSTOMER ALSO REPORTED THAT THE LID DOES NOT OPEN PROPERLY ANYMORE AND THAT THEY USED SCISSORS TO HELP OPENING THE INSTRUMENT. WHEN THEY PLUGGED THE INSTRUMENT OUT AND BACK INTO THE SOCKET DURING THE CALL THERE WAS AN ELECTRIC DISCHARGE/SPARK. THE CUSTOMER CONFIRMED THAT THIS DID NOT TOUCH HER AND THAT SHE WAS UNHARMED. (B)(6) 2024 CUSTOMER CONFIRMED SPARK OCCURRED WHEN CABLE WAS PLUGGED INTO BACK OF THE INSTRUMENT.

Additional Manufacturer Narrative

THE CUSTOMER ALSO ADVISED THEY SHOULD NEVER USE ANYTHING ELSE APART FROM THE NORMAL FUNCTION TO OPEN THE INSTRUMENT AND THAT USING ANY KIND OF TOOLS IS VERY DANGEROUS AND CAN LEAD TO PHYSICAL HARM. TS ALSO ADVISED THE CUSTOMER TO LEAVE THE INSTRUMENT UNPLUGGED AND NOT USE IT AGAIN.