BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE ULTRA CONSUMABLE

    MDR report key: 7142180 · Received December 22, 2017

    Report

    Report Number
    1218996-2017-00041
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    January 12, 2015
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAGELLAN'S INVESTIGATIONS HAVE CONFIRMED THAT EXTENDED INCUBATION (IE OVERNIGHT) OF BLOOD/TREATMENT REAGENT MIXTURES AT ROOM TEMPERATURE OR INCUBATION AT HIGH TEMPERATURES (IE, 60 C) IMPROVED TEST RESULTS FOR SOME BLOOD SPECIMENS. STUDIES SUGGEST THE VENOUS BLOOD COLLECTION TUBE CONTRIBUTES TO THE LOW RESULTS AS SIMILAR LOW RESULTS ARE NOT OBSERVED WITH CAPILLARY BLOOD SAMPLES. MAGELLAN IS CONTINUING INVESTIGATIONS ON TO DETERMINE ROOT CAUSE OF SUPPRESSED RESULTS WITH VENOUS BLOODS. CURRENT LABELING INDICATES THAT VENOUS SAMPLES SHOULD NOT BE USED ON THE LEADCARE SYSTEM. SAME DEVICE KIT FROM CUSTOMER COULD NOT BE USED. THE LOT 1404AU MATERIALS WERE FROM MAGELLAN INVENTORY. (B)(4). LATE FILING IS PART OF MAGELLAN DIAGNOSTICS, INC. RESPONSE TO FDA'S 483 ISSUED ON 29JUN2017.

    Description of Event or Problem · 1

    BLOOD/TREATMENT REAGENT MIXTURES TESTED WITH LEADCARE ULTRA PRODUCE RESULTS AT TIME T=0 THAT ARE LOWER THAN WHEN THE MIXTURE IS HELD AND THEN TESTED AT T=24, AND T=48.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923079 LEADCARE ULTRA CONSUMABLE LEADCARE ULTRA TEST KIT DOF MAGELLAN DIAGNOSTICS 1404AU 00850355006024

    Patients

    Seq Age Sex Outcome Treatment
    1