BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFINION 2

    MDR report key: 11011942 · Received December 15, 2020

    Report

    Report Number
    3003045237-2020-00009
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    December 9, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K182988
    Removal / Correction Number
    9613069-02/03/2020-001/C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN ADDED/CORRECTED: SECTION G5: UPDATED EVENT DESCRIPTION WITH MORE DETAILS. CHANGED INSTRUMENT TO ADAPTER IN FIRST LINE. SECTION H7 REMEDIAL ACTIONS: SELECTED RECALL AS REMEDIAL ACTION REQUIRED AS THIS EVENT HAS BEEN LINKED TO AN ONGOING RECALL. SECTION H9: ADDED CORRECTION REPORTING NUMBER FOR ONGOING RECALL.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THERE WAS A SHORT CIRCUIT OUTSIDE THE LAB DUE TO A SUDDEN SURGE IN THE VOLTAGE. THE AFINION ADAPTER CONNECTED TO THE AFINION INSTRUMENT AND SOME LAPTOPS UNRELATED TO THE AFINION INSTRUMENT WERE BURNT. THE CUSTOMER OBSERVED SPARKS IN THE POWER SOCKET AND IN THE ADAPTER, AND THERE WAS A BURNT SMELL. THERE WAS NO SOOTING, SCORCHING OR BURN MARKS. THERE WAS NO INJURY. THE INSTRUMENT WAS CHECKED WITH ANOTHER ADAPTOR IN THE LAB AND THE CUSTOMER REPORTED THAT THE INSTRUMENT WORKED WITH THE OTHER CABLE. THE INSTRUMENT AND POWER ADAPTER IS RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE ISSUE WAS ELECTRICAL OVERSTRESS FROM OUTSIDE THE LAB, WHICH THE POWER SUPPLY WAS NOT ABLE TO WITHSTAND. THE POWER SUPPLY WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THERE WAS A SHORT CIRCUIT OUTSIDE THE LAB DUE TO A SUDDEN SURGE IN THE VOLTAGE. THE AFINION INSTRUMENT AND ALSO SOME LAPTOPS GOT BURNT. THE CUSTOMER OBSERVED SPARKS IN THE POWER SOCKET AND IN THE ADAPTER, AND THERE WAS A BURNT SMELL. THERE WAS NO SOOTING, SCORCHING, OR BURN MARKS. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476135 AFINION 2 ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1116772

    Patients

    Seq Age Sex Outcome Treatment
    1