BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 12590318 · Received October 7, 2021

    Report

    Report Number
    3003045237-2021-00092
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 16, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K180296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSTRUMENT WAS SENT TO CUSTOMERS IN MARCH 2016 AND WOULD HAVE AN NEW POWER CORD AS AN ACTION OF FSCA THE INSTRUMENT WAS RETURNED BY CUSTOMER ON 26/9/2021, HOWEVER AS OF 31 MAY 2022 THE INSTRUMENT HAS NOT BEEN RECIVED IN THE 260 DAYS SINCE REPORTED. THE INVESTIGATION IS NOW CLOSED AS A RESULT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED SPARKING FROM THE AS100 (THE ANALYZER ITSELF). THERE WAS NO SPARKING FROM THE POWER CORD OR THE OUTLET. THE SPARK OCCURRED WHEN THE CUSTOMER WAS TOUCHING THE ON/OFF BUTTON TO TURN ON THE INSTRUMENT. THE CUSTOMER WAS USING THE NEW VERSION OF THE POWER SUPPLY (MASCOT), SERIAL NUMBER (B)(6). -NO EXPLOSION. -NO FLAMING. -NO SMOKING. -NO CHARRING. -NO BURNING. -NO MELTED PLASTIC. -NO DEATH. -NO SERIOUS INJURY. NO CLINICAL IMPACT AS NO PATIENT INVOLVED AND NO ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SPARKING FROM THE AS100 (THE ANALYZER ITSELF). THERE WAS NO SPARKING FROM THE POWER CORD OR THE OUTLET. THE SPARK OCCURRED WHEN THE CUSTOMER WAS TOUCHING THE ON/OFF BUTTON TO TURN ON THE INSTRUMENT. THE CUSTOMER WAS USING THE NEW VERSION OF THE POWER SUPPLY (MASCOT), SERIAL NUMBER (B)(4) WITH ANALYSER SERIAL NUMBER (B)(4): NO EXPLOSION, NO FLAMING, NO SMOKING, NO CHARRING, NO BURNING, NO MELTED PLASTIC, NO DEATH, NO SERIOUS INJURY. NO CLINICAL IMPACT AS NO PATIENT INVOLVED AND NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489774 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1115175 10182271

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown