BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADCARE ULTRA CONSUMABLES

    MDR report key: 9159258 · Received October 4, 2019

    Report

    Report Number
    1218996-2019-00025
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    October 22, 2014
    Report Date
    October 4, 2019
    Manufacturer
    MAGELLAN DIAGNOSTICS, INC.
    Product Code
    DOF
    UDI-DI
    00850355006024
    PMA / PMN Number
    K123563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1218996-2017-00038 ADDENDUM. 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. COMMENT: SAME DEVICE KIT FROM CUSTOMER COULD NOT BE USED. THE LOT 1312BU MATERIALS WERE FROM MAGELLAN INVENTORY. CUSTOMER'S INVENTORY WAS EXHAUSTED. LATE FILING IS PART OF MAGELLAN DIAGNOSTICS, INC. RESPONSE TO FDA'S 483 ISSUED ON 29JUN2017. COMPLAINT # (B)(4). TESTING WAS ALL DONE ON (B)(6) 2017 AND PATIENT SAMPLE RESULTS FOR LCU VS ESA VS ICP-MS (IN UG/DL) WERE ALL FILLED UNDER ONE MDR. WE WILL NOW BE SUBMITTING SEPARATE MDRS FOR EACH INDIVIDUAL PATIENT RESULT. RESULTS: (LCU VS ESA VS ICP-MS) 2 VS 10.5 [1218996-2019-00016], 3.8 VS 9.8 [1218996-2019-00017], 4.2 VS 8.7 [1218996-2019-00021], 2 VS 6.5 [1218996-2019-00022], 2 VS 6.6 [1218996-2019-00023], 2.5 VS 8.7 [1218996-2019-00024], 2 VS 6 [1218996-2019-00025], 15.6 VS 21.2 [1218996-2019-00026], 15.4 VS 20.6 [1218996-2019-00027]. AFTER FURTHER INVESTIGATION IT HAS BEEN CONFIRMED THAT SOME OF THE BLOOD LEAD SAMPLE RESULTS ARE NOT CONSIDERED REPORTABLE EVENTS. SEE THE DATA BELOW: 7.7 VS 14.6 [NOT REPORTABLE], 5.1 VS 10.6 [NOT REPORTABLE], 9.2 VS 16.1 [NOT REPORTABLE], 2 VS 4.6 [NOT REPORTABLE].

    Description of Event or Problem · 1

    MDR 1218996-2017-00038 ADDENDUMCUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951098 LEADCARE ULTRA CONSUMABLES LEADCARE ULTRA DOF MAGELLAN DIAGNOSTICS, INC. LEADCARE ULTRA 1312BU 00850355006024

    Patients

    Seq Age Sex Outcome Treatment
    1