BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE ULTRA CONSUMABLE

    MDR report key: 7142430 · Received December 22, 2017

    Report

    Report Number
    1218996-2017-00025
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    January 13, 2017
    Report Date
    December 22, 2017
    Manufacturer
    MAGELLAN DIAGNOSTICS
    Product Code
    DOF
    UDI-DI
    00850355006024
    PMA / PMN Number
    K123563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING CONDUCTED AT MAGELLAN USING RETENTION SAMPLES OF THE SAME LOT NUMBER OF LEADCARE ULTRA PRODUCED THE EXPECTED RESULTS. UNABLE TO CONFIRM CUSTOMER'S COMPLAINT WITH TEST SAMPLES IN THE RANGE OF 5-10 UG/DL.. LATE FILING IS PART OF MAGELLAN DIAGNOSTICS, INC. RESPONSE TO FDA'S 483 ISSUED ON 29JUN2017. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER WAS COMPARING PATIENT DATA OBTAINED WITH LEADCARE ULTRA AND GRAPHITE FURNACE ATOMIC ABSORPTION SPECTROPHOTOMETRY (GFAAS). ON THE ULTRA, SOME RESULTS WERE FALSELY SUPPRESSED IN COMPARISON TO THE GFAAS REFERENCE METHOD. THERE WERE 7 CASE SAMPLES OUT OF 11 SAMPLES TESTED WHERE RESULTS WERE FALSELY SUPPRESSED AT CLINICALLY RELEVANT MEDICAL THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920752 LEADCARE ULTRA CONSUMABLE LEADCARE ULTRA DOF MAGELLAN DIAGNOSTICS LEADCARE ULTRA 1609NU 00850355006024

    Patients

    Seq Age Sex Outcome Treatment
    1