BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE ULTRA CONSUMABLE

    MDR report key: 7142171 · Received December 22, 2017

    Report

    Report Number
    1218996-2017-00039
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    October 28, 2014
    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

    SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED). BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923071 LEADCARE ULTRA CONSUMABLE LEADCARE ULTRA TEST KIT DOF MAGELLAN DIAGNOSTICS 1404AU 00850355006024

    Patients

    Seq Age Sex Outcome Treatment
    1