BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 11744655 · Received April 29, 2021

    Report

    Report Number
    3003045237-2021-00002
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 25, 2023
    Manufacturer
    ABBOTT DIAGNOTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K180296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WILL BE RETURNED TO THE MANFUCATURER FOR INVESTIGATION. THE INCIDENT RELATES TO THE OLD POWER SUPPLY. THE INSTRUMENT WAS RETURNED BUT UNFORTUNATELY THE POWER SUPPLY WASN'T INCLUDED IN THE RETURN PACKAGE. THERE WAS NO INDICATION OF SOOT OR BURN ON THE INSTRUMENT AND IT STARTED UP WHEN USED WITH A NEW POWER SUPPLY. AFINION CRP CONTROL WAS TESTED AND PASSED, AS WELL. IN CONCLUSION, THE ISSUE IS CONSIDERED RELATED TO THE POWER SUPPLY USED AT THE MOMENT OF THE EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THERE HAD BEEN SPARKS COMING FROM THE CONNECTION BETWEEN THE AFINION S100 INSTRUMENT (SERIAL NUMBER (B)(6)) AND THE POWER SUPPLY (SERIAL NUMBER (B)(6)). CUSTOMER REPORTED THAT THEY THOUGHT THE FAULT WAS WITH THE POWER SUPPLY AS THEY HAD TRIED TO POWER ON THE INSTRUMENT USING A POWER SUPPLY FROM ANOTHER INSTRUMENT AND IT SEEMED TO WORK. CUSTOMER HAS NOT USED THE INSTRUMENT SINCE THE INCIDENT. CUSTOMER CONFIRMED NO ONE WAS HARMED BY THE OBSERVED SPARKS AND NO ONE HAD EXPERIENCED STATIC ELECTRIC ISSUES AT ANY TIME. POWER SUPPLY WILL BE RETURNED TOGETHER WITH THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INCIDENT RELATES TO THE OLD POWER SUPPLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE HAD BEEN SPARKS COMING FROM THE CONNECTION BETWEEN THE AFINION S100 INSTRUMENT (SERIAL NUMBER (B)(4)) AND THE POWER SUPPLY (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT THEY THOUGHT THE FAULT WAS WITH THE POWER SUPPLY AS THEY HAD TRIED TO POWER ON THE INSTRUMENT USING A POWER SUPPLY FROM ANOTHER INSTRUMENT AND IT SEEMED TO WORK. CUSTOMER HAS NOT USED THE INSTRUMENT SINCE THE INCIDENT. CUSTOMER CONFIRMED NO ONE WAS HARMED BY THE OBSERVED SPARKS AND NO ONE HAD EXPERIENCED STATIC ELECTRIC ISSUES AT ANY TIME. POWER SUPPLY WILL BE RETURNED TOGETHER WITH THE INSTRUMENT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646802 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOTICS TECHNOLOGIES AS 1116053 10185355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown