BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX ANALYZER

    MDR report key: 7446025 · Received April 20, 2018

    Report

    Report Number
    3002807968-2018-00021
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 20, 2018
    Report Date
    November 12, 2018
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CHL
    UDI-DI
    05700693930909
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOMETER MEDICAL APS CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, THE HEAD OF THE CENTRAL LABORATORY REPORTED THAT THE PULMONARY DEPARTMENT ON (B)(6) 2018, EXPERIENCED A MISMATCH BETWEEN THE SCANNED PATIENT ID OF THE PATIENT AND THE PATIENT ID ON THE PRINTOUT. THE PATIENT SCANNED HAD ID (("PNR") (B)(6) BUT THE PRINTOUT WAS DISPLAYED AS PATIENT ID (B)(6). THIS WAS THE SECOND TIME THAT THIS EVENT OCCURRED ACCORDING TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289169 ABL90 FLEX ANALYZER ABL90 FLEX ANALYZER CHL RADIOMETER MEDICAL APS 393-090 05700693930909

    Patients

    Seq Age Sex Outcome Treatment
    1