BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 19576068 · Received June 20, 2024

    Report

    Report Number
    9613069-2024-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 7, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K182988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON 07 JUNE, 2024 A CUSTOMER PHONED TECHNICAL SERVICES (TS) TO REPORT THAT THEIR INSTRUMENT WAS HAVING LID ISSUES. THE CUSTOMER (ANALYZER USER) EXPLAINED THEY WERE RUNNING AN AFINION CRP TEST WHEN THE ANALYZER STARTED DISPLAYING FOLLOWING INFORMATION CODES, EVEN THOUGH THE CARTRIDGE WAS NOT RE-USED: - 208 (TEST CARTRIDGE PREVIOUSLY USED) - 302 (ANALYZER FAILURE) THE LID THEN STARTED MAKING VERY LOUD NOISES, AND WAS OPENING AND CLOSING BY ITSELF. THE CUSTOMER PUSHED THE LID TO CLOSE IT, HOWEVER IT OPENED UP AGAIN. THE CUSTOMER THEN INFORMED TS THAT THEY TRIED TO TURN OFF THE INSTRUMENT BY CLICKING THE BUTTON, BUT IT WAS NOT RESPONDING. THEY DECIDED TO PULL THE PLUG, WHERE CUSTOMER THEN RECEIVED AN ELECTRIC SHOCK. THE CUSTOMER TRIED TO RUN ANOTHER TEST (AFINION HBA1C), BUT THE LID CONTINUED MAKING LOUD NOISES AND NOT RESPONDING, CLOSING AND OPENING BY ITSELF. THE CUSTOMER STATED THAT THE INSTRUMENT WORKED FINE BEFORE THE DAY OF THIS EVENT. THE ANALYZER IS IN A DRY ENVIRONMENT, PLACED ON A STABLE TABLE (NO VIBRATION), AWAY FROM SUNLIGHT. PLUGGED INTO AN EXTENSION CORD. THERE WAS AT LEAST 30 CM BETWEEN OTHER DEVICES AND THE AFINION 2 INSTRUMENT. CUSTOMER INFORMS THE ROOM IS NOT WARM, HOWEVER THEY DID NOTICE THAT THE INSTRUMENT HAD 30 DEGREES DISPLAYED ON THE SCREEN BEFORE TS ASKED THE CUSTOMER TO TURN IT OFF. CUSTOMER INFORMED THE INSTRUMENT WAS NOT WARM TO TOUCH. THERE WAS NO VISIBLE SMOKE, EVIDENCE OF FIRE, STATIC ELECTRICAL ISSUE, CHARRING, BURNT SMELL, SCORCH MARKS. ON (B)(6) 2024 THE CUSTOMER CONFIRMED WITH TS THE ELECTRIC SHOCK CAME FROM THE BACK OF THE ANALYZER WHILE PULLING THE PLUG OUT OF AN EXTENSION CORD. CUSTOMER ALSO INFORMED THAT THEY WERE FINE, AND NOT IMPACTED BY THE SHOCK, AS IT WAS VERY MINIMAL.

    Description of Event or Problem · 0

    ON 07 JUNE, 2024 A CUSTOMER PHONED TECHNICAL SERVICES (TS) TO REPORT THAT THEIR INSTRUMENT WAS HAVING LID ISSUES. THE CUSTOMER (ANALYZER USER) EXPLAINED THEY WERE RUNNING AN AFINION CRP TEST WHEN THE ANALYZER STARTED DISPLAYING FOLLOWING INFORMATION CODES, EVEN THOUGH THE CARTRIDGE WAS NOT RE-USED: 208 (TEST CARTRIDGE PREVIOUSLY USED), 302 (ANALYZER FAILURE). THE LID THEN STARTED MAKING VERY LOUD NOISES, AND WAS OPENING AND CLOSING BY ITSELF. THE CUSTOMER PUSHED THE LID TO CLOSE IT, HOWEVER IT OPENED UP AGAIN. THE CUSTOMER THEN INFORMED TS THAT THEY TRIED TO TURN OFF THE INSTRUMENT BY CLICKING THE BUTTON, BUT IT WAS NOT RESPONDING. THEY DECIDED TO PULL THE PLUG, WHERE CUSTOMER THEN RECEIVED AN ELECTRIC SHOCK. THE CUSTOMER TRIED TO RUN ANOTHER TEST (AFINION HBA1C), BUT THE LID CONTINUED MAKING LOUD NOISES AND NOT RESPONDING, CLOSING AND OPENING BY ITSELF. THE CUSTOMER STATED THAT THE INSTRUMENT WORKED FINE BEFORE THE DAY OF THIS EVENT. THE ANALYZER IS IN A DRY ENVIRONMENT, PLACED ON A STABLE TABLE (NO VIBRATION), AWAY FROM SUNLIGHT. PLUGGED INTO AN EXTENSION CORD. THERE WAS AT LEAST 30 CM BETWEEN OTHER DEVICES AND THE AFINION 2 INSTRUMENT. CUSTOMER INFORMS THE ROOM IS NOT WARM, HOWEVER THEY DID NOTICE THAT THE INSTRUMENT HAD 30 DEGREES DISPLAYED ON THE SCREEN BEFORE TS ASKED THE CUSTOMER TO TURN IT OFF. CUSTOMER INFORMED THE INSTRUMENT WAS NOT WARM TO TOUCH. THERE WAS NO VISIBLE SMOKE, EVIDENCE OF FIRE, STATIC ELECTRICAL ISSUE, CHARRING, BURNT SMELL, SCORCH MARKS. ON (B)(6) 2024 THE CUSTOMER CONFIRMED WITH TS THE ELECTRIC SHOCK CAME FROM THE BACK OF THE ANALYZER WHILE PULLING THE PLUG OUT OF AN EXTENSION CORD. CUSTOMER ALSO INFORMED THAT THEY WERE FINE, AND NOT IMPACTED BY THE SHOCK, AS IT WAS VERY MINIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155882 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116778 10216716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female