BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE AFINION AS100 ANALYZER

    MDR report key: 16501576 · Received March 8, 2023

    Report

    Report Number
    9613069-2023-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    October 23, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS TECHNOLOGIES AS
    Product Code
    JQT
    PMA / PMN Number
    K180269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DETAILS WERE REVIEWED ALONG WITH INTERNAL RECORDS AND NO NONCONFORMANCES WERE IDENTIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED IN THE COMPLAINT. OUR INVESTIGATION DETERMINED THAT THERE IS NO INDICATION THAT THE REPORTED ISSUE IS RELATED TO PRODUCT RESULTS, INADEQUATE INSTRUCTIONS FOR USE OR INACCURATE LABELING. CUSTOMER COMPLAINTS WILL CONTINUE TO BE MONITORED TO ENSURE CONTROL LIMITS ARE NOT EXCEEDED AND ENSURE PRODUCT'S PERFORMANCE MEETS CUSTOMERS' EXPECTATIONS. UPDATES TO THE SUPPLEMENT: D4: LOT NUMBER ADDED H6: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION AND INVESTIGATION CONCLUSIONS, ALL UPDATED FROM INITIAL REPORT. H3 OTHER TEXT : DEVICE HAS BEEN REQUESTED, HOWEVER HAS NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    DEVICE REQUESTED, BUT NOT YET RETURNED.

    Description of Event or Problem · 0

    ON 10 FEB 2023 A CUSTOMER PHONED TECHNICAL SERVICES (TS) TO REPORT SEEING A SPARK WHEN PLUGGING IN THEIR AFINION AS100 ANALYZER WITH SERIAL NUMBER (B)(6). POWER CORD WAS PLUGGED INTO MAIN WALL OUTLET. CUSTOMER WAS UNABLE TO PROVIDE SOFTWARE VERSION AS THE MACHINE WAS NOT PLUGGED IN. TECHNICAL SERVICES ASKED INTAKE QUESTIONS AS PER (B)(4) AF AND NOTED NO DEVIATIONS. NO INJURIES OCCURRED.

    Description of Event or Problem · 0

    ON (B)(6) 2023 A CUSTOMER PHONED TECHNICAL SERVICES (TS) TO REPORT SEEING A SPARK WHEN PLUGGING IN THEIR AFINION AS100 ANALYZER WITH SERIAL NUMBER (B)(4). POWER CORD WAS PLUGGED INTO MAIN WALL OUTLET. CUSTOMER WAS UNABLE TO PROVIDE SOFTWARE VERSION AS THE MACHINE WAS NOT PLUGGED IN. TECHNICAL SERVICES ASKED INTAKE QUESTIONS AS PER D10035781 AF AND NOTED NO DEVIATIONS. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121456 ALERE AFINION AS100 ANALYZER ANALYZER JQT ABBOTT DIAGNOSTICS TECHNOLOGIES AS 1115175 10175122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown