BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1597683 · Received February 10, 2010

    Report

    Report Number
    1823260-2010-00910
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    January 21, 2010
    Report Date
    April 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PATIENT SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ALL REPLICATES OF THE RETURNED CUSTOMER PATIENT SAMPLES RECOVERED 0.00 ON THE MODULAR AND <0.20 ON THE INTEGRA. ABSORBANCE DATA FOR ALL REPLICATES OF ALL RETURNED CUSTOMER PATIENT SAMPLES WERE ABOVE THAT OF THE 0 CALIBRATOR FOR BOTH INSTRUMENT ASSAYS. THIS IS CONSISTENT WITH THE NON-SPECIFIC AGGLUTINATION PHENOMENON THAT IS DESCRIBED IN THE PACKAGE INSERTS FOR BOTH ASSAYS. "IN RARE INSTANCES (<1%), SAMPLES CONTAIN UNIDENTIFIED COMPONENT(S) WHICH CAUSE NON-SPECIFIC AGGLUTINATION IN THIS ASSAY. THESE SAMPLES GIVE FALSELY LOWERED DIGOXIN VALUES". NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HEMI-COLECTOMY PROCEDURE, A VASCULAR RELOAD WAS USED IN A REGULAR GUN. THE DEVICE WAS FIRED AND ONLY TWO ROWS OF STAPLES WERE DEPLOYED. THERE WAS BLEEDING THAT THEY WERE ABLE TO CONTROL INTRA-OPERATIVELY. AFTER FIRING, THE DEVICE WAS DIFFICULT TO REMOVE. THEY WERE ABLE TO GET IT OFF THE TISSUE. ONCE REMOVED, THERE WAS DAMAGE TO THE TISSUE THAT WAS REPAIRED. NO BLOOD PRODUCT WAS REQUIRED. NO DEVICE RETURNING.

    Description of Event or Problem · 1

    THE USER RECEIVED A DIGOXIN RESULT OF ZERO WHICH WAS DUPLICATED UPON REPEAT TESTING. THE SAMPLE WAS THEN SENT TO ANOTHER SITE AND TESTED ON THE CENTAUR WITH A RESULT OF 1.5 (NO UNIT OF MEASURE PROVIDED.) NO INFORMATION WAS PROVIDED TO DETERMINE IF THE RESULT WAS REPORTED OR IF THE PATIENT WAS ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 803525. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINCIAL CHEMISTRY ANALYZER KXT ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR ESOMEPRAZOLE| WARFARIN| DIGOXIN| ATENOLOL| ZOLOFT