BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2 ANALYZER

    MDR report key: 12704533 · Received October 27, 2021

    Report

    Report Number
    3003045237-2021-00005
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 4, 2021
    Report Date
    June 16, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K171650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN TAB WAS ISSUED ONCE WARRANTY SEAL WAS RECEIVED, HOWEVER INSTRUMENT HAS NOT BEEN RECEIVED AT OSLO SITE.

    Description of Event or Problem · 0

    THE CUSTOMER WAS FACING AN ISSUE WITH THE AFINION 2 ANALYZER. (S/N: (B)(6)) - REPORT OF AUTOMATICALLY SHUTTING DOWN - STARTUP FAILURE. THE CUSTOMER AND ABBOTT EMPLOYEE GAVE THE INFORMATION OVER THE PHONE. - THE INSTRUMENT SWITCHES OFF DURING THE SELF-TEST IN SECONDS AUTOMATICALLY. - THEY EVEN PERFORMED THE TROUBLESHOOTING BELOW AND STILL, THE ISSUE PERSISTS. CUSTOMER REPORTED SLIGHT SPARK WITH SLIGHT SHOCK FROM THE ADAPTER (POWER CORD) OF AFINION 2. UPON SWITCHING OFF THE MAIN, THE ADAPTER (POWER CORD) WAS STILL SHOWING THE BLUE LIGHT FOR A FEW SECONDS BEFORE GOING OFF. DURING THAT TIME THE CUSTOMER TRIED TO REMOVE AND RECONNECT THE ADAPTER TO THE INSTRUMENT WHICH GAVE A SLIGHT SPARK AND THERE WAS A SLIGHT SHOCK. THERE WAS A CRACK IN THE MAINS CORD, WHERE IT CONNECTS TO THE POWER SUPPLY. THE CUSTOMER WAS USING POWER SUPPLY MASCOT BLUE. AFINION 2 ANALYZER SERIAL NUMBER: (B)(6). NO INFORMATION TO POWER CORD SERIAL NUMBER. - VISIBLE SMOKE - NO. - EVIDENCE OF FIRE - NO. - STATIC ELECTRICAL ISSUE - NO. - ELECTRICAL SHOCK (NOT STATIC ISSUE) - SLIGHT SPARK WITH SLIGHT SHOCK. - CHARRING - NO. - BURNT SMELL - NO. - SCORCH MARKS - NO. - INSTRUMENT BEING WARM/HOT TOO TOUCH - NO. NO CLINICAL IMPACT. INVESTIGATION VIA CUSTOMER COMMUNICATION IDENTIFIED A BROKEN ARE ON THE INSTRUMENT WHERE THE POWER CORD CONNECTS. AS OF MAY 31 2022 THE PRODUCT PROBLEM COMPLAINT HAD BEEN OPENED FOR 293 DAYS AND THE INSTRUMENT HAS BOT BEEN RECIEVED, RETURN TESTING WAS NOT ABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER WAS FACING AN ISSUE WITH THE AFINION 2 ANALYZER. (S/N: (B)(4)): REPORT OF AUTOMATICALLY SHUTTING DOWN - STARTUP FAILURE. THE CUSTOMER AND ABBOTT EMPLOYEE GAVE THE INFORMATION OVER THE PHONE. THE INSTRUMENT SWITCHES OFF DURING THE SELF-TEST IN SECONDS AUTOMATICALLY. THEY EVEN PERFORMED THE TROUBLESHOOTING BELOW AND STILL, THE ISSUE PERSISTS. CUSTOMER REPORTED SLIGHT SPARK WITH SLIGHT SHOCK FROM THE ADAPTER (POWER CORD) OF AFINION 2. UPON SWITCHING OFF THE MAIN, THE ADAPTER (POWER CORD) WAS STILL SHOWING THE BLUE LIGHT FOR A FEW SECONDS BEFORE GOING OFF. DURING THAT TIME THE CUSTOMER TRIED TO REMOVE AND RECONNECT THE ADAPTER TO THE INSTRUMENT WHICH GAVE A SLIGHT SPARK AND THERE WAS A SLIGHT SHOCK THERE WAS A CRACK IN THE MAINS CORD, WHERE IT CONNECTS TO THE POWER SUPPLY. THE CUSTOMER WAS USING POWER SUPPLY MASCOT BLUE. AFINION 2 ANALYZER SERIAL NUMBER: (B)(4). NO INFORMATION TO POWER CORD SERIAL NUMBER. VISIBLE SMOKE: NO EVIDENCE OF FIRE: NO STATIC ELECTRICAL ISSUE: NO ELECTRICAL SHOCK (NOT STATIC ISSUE): SLIGHT SPARK WITH SLIGHT SHOCK. CHARRING: NO. BURNT SMELL: NO. SCORCH MARKS: NO. INSTRUMENT BEING WARM/HOT TOO TOUCH: NO. NO CLINICAL IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603222 AFINION 2 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116681 10201288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown