BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ 200 URINE ANALYZER

    MDR report key: 12408852 · Received September 1, 2021

    Report

    Report Number
    2122870-2021-00134
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 2, 2021
    Report Date
    September 1, 2021
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    KQO
    UDI-DI
    10837461001300
    PMA / PMN Number
    K022774
    Removal / Correction Number
    2050012-03/25/2020-004C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE DVD RW'S POWER PLUG WAS BURNT, SHOWING CHARRING AND A MELTED/BURNT CONNECTOR ON THE SATA PORT OF THE DVD-RW. TO RESOLVE THE ISSUE A DVD RW REPLACEMENT WAS ORDERED. THE CAUSE OF THE FAILURE CAN BE ATTRIBUTED TO THE DVD RW CABLE. THE ROOT CAUSE WAS ATTRIBUTED TO DIELECTRIC BREAKDOWN OF THE CABLE'S MOLDING. AN IMAGE WAS PROVIDED ON AUGUST 13, 2021 FOR THE PC6 SERIAL NUMBER. THE SERIAL NUMBER SHOWN IS (B)(4). THIS SERIAL NUMBER WAS VERIFIED AND FOUND LISTED AS PART OF CAT 1 MOD 12500 AS A CORRECTION PER (B)(4) ((B)(4) (FDA RECALL ID: Z-1944-2020 AND Z-1945-2020)) FOR PC6 SATA ADAPTER CABLE. THE MOD COMPLETION IS SCHEDULED FOR NOVEMBER 6, 2021. BEC INTERNAL IDENTIFIER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPUTER ON THEIR IQ 200 URINE ANALYZER GENERATED A SPARK AND BLEW THE FUSES OF THE LABORATORY. THE DVD RW'S POWER PLUG WAS BURNT, SHOWING CHARRING AND A MELTED/BURNT CONNECTOR ON THE SATA PORT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WAS VISIBLE SMOKE OBSERVED. A FIRE EXTINGUISHER WAS NOT USED. THE FIRE DEPARTMENT WAS NOT CALLED AND THE LAB AS NOT EVACUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302865 IQ 200 URINE ANALYZER AUTOMATED URINALYSIS SYSTEM KQO BECKMAN COULTER IRELAND INC. IQ200 SELECT 2008 TESTED 10837461001300

    Patients

    Seq Age Sex Outcome Treatment
    1