BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 10228327 · Received July 3, 2020

    Report

    Report Number
    3003045237-2020-00006
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 2, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K151809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A INVESTIGATION IS ONGOING FOR AFINION ANALYZERS RELATED TO SIMILAR INCIDENTS AND THE INVESTIGATION TO DATE HAS CONCLUDED THAT ELECTRIC SHOCK HAS NOT BEEN DEMONSTRATED WITH THE ANALYZERS. RATHER, STATIC DISCHARGE MAY BE POSSIBLE AND IS MORE CONSISTENT WITH THE DESCRIPTION OF THE INCIDENT. PER THE HEALTH HAZARD EVALUATION STATIC DISCHARGE DOES NOT POSE A RISK TO HARM WHEREAS BREACH OF POWER SUPPLY COULD HAVE THE POTENTIAL TO RESULT IN BURN INJURY. AS THE COMPLAINT IS NOT CLEAR IF THIS COULD BE A POTENTIAL BREACH, AN MDR IS FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AFINION AS100 ANALYZER SPARKED WHEN PLUGGED INTO THE WALL. THERE WAS NO CHARRING OR BURNING. THE CUSTOMER DISCONNECTED THE INSTRUMENT AFTER THE INCIDENT AND THE INSTRUMENT HAS NOT BEEN USED SINCE. THE CUSTOMER DESCRIBED THAT SHE FELT AN ELECTRIC SHOCK IN HER ARM. NO INJURY WAS REPORTED. THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS ON THE SPARKING AND IT COULD BE CAUSED BY ELECTROSTATIC DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694630 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1115175 AS0057766

    Patients

    Seq Age Sex Outcome Treatment
    1