BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 10996245 · Received December 12, 2020

    Report

    Report Number
    3003045237-2020-00008
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Date of Event
    June 11, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K180296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWARE DATE FOR THE EVENT WAS (B)(6) 2020, AND THE INITIAL ASSESSMENT OF REPORTABILITY CONCLUDED THAT THE INCIDENT WAS NOT REPORTABLE. THE INSTRUMENT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION SHOWS SMALL MARKS ON THE INSTRUMENT COVER, AND ON THE POWER SUPPLY PLUG. THE CUSTOMER REPORTED THAT WHEN THE INCIDENT HAPPENED THE POWER SUPPLY WAS CONNECTED TO THE WALL OUTLET BEFORE SHE ATTEMPTED TO INSERT THE POWER SUPPLY INTO THE INSTRUMENTS. THE USER MANUAL FOR THE INSTRUMENT INSTRUCTS THE USER TO CONNECT IN THE FOLLOWING 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 THE POWER CORD TO WALL A OUTLET. THE CONNECTOR AT THE LOW VOLTAGE END OF THE POWER SUPPLY IS TO BE CONNECTED TO THE INSTRUMENT. THE INVESTIGATION SHOWED THAT IT'S HIGHLY LIKELY THAT SPARKS OCCURRED WHEN THE TWO POLES ON THE POWER SUPPLY CONNECTOR AT THE LOW VOLTAGE END OF THE POWER SUPPLY WERE SHORTED AGAINST THE INSTRUMENT COVER AT THE BACK SIDE OF THE INSTRUMENT. POWER SUPPLY FAIL-SAFE MECHANISM IMMEDIATELY DISABLES THE OUTPUT VOLTAGE UNTIL SHORT IS REMOVED. WHEN SHORT IS REMOVED, OUTPUT VOLTAGE IS ENABLED AUTOMATICALLY. THIS MECHANISM LIMITS THE NUMBER OF SPARKS. TESTING HAS SHOWN LOW LIKELIHOOD OF SPARKING REPRESENTING A FIRE HAZARD. A MEDICAL REVIEW HAS SINCE CONCLUDED THAT THIS INCIDENT WAS REPORTABLE IN THE EVENT OF HARM. THE INCIDENT IS THEREFORE REPORTED AS A CONSERVATIVE APPROACH.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A TEST CASSETTE HAS BEEN STUCK IN THE INSTRUMENT, AFINION AS100 (SERIAL NO. (B)(4)). THE CUSTOMER UNPLUGGED THE POWER CABLE FROM THE INSTRUMENT AND THEN PLUGGED IT BACK INTO THE INSTRUMENT. THE CUSTOMER EXPERIENCED SPARKS FROM THE INSTRUMENT WHEN THE POWER CABLE CAME IN CONTACT WITH THE POWER CABLE INLET OF THE INSTRUMENT. THE SPARKS OCCURRED WHEN THE CABLE TOUCHED THE INSTRUMENT AND THE SPARKS DISAPPEARED WHEN THERE WAS NO CONTACT BETWEEN THE CABLE AND THE INSTRUMENT. THE CUSTOMER DESCRIBED A BURNT SMELL AFTER THE INCIDENT. THERE WAS NO INJURY REPORTED BUT THE CUSTOMER EXPLAINED THAT SHE WAS SCARED BY THE INCIDENT. THE CUSTOMER CONFIRMED THERE WAS NO ELECTRIC SHOCK INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459885 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116053

    Patients

    Seq Age Sex Outcome Treatment
    1