BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC READER

    MDR report key: 1812669 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05018
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 12, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K000784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED A LIKELY CAUSE OF THE DISCREPANT RESULT WAS THE WRONG HANDLING OF THE BLOOD SAMPLE RELATED TO THE SAMPLE STABILITY. THE STATED SAMPLE STABILITY IS 8 HOURS AT ROOM TEMPERATURE. THE RETURNED STRIPS AS WELL AS RETENTION PRODUCTS PERFORMED AS EXPECTED AND NO MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL 1 STENTING PROCEDURE, A EMBOSHIELD NAV6 FILTER WAS DEPLOYED ON A NON-ABBOTT STABILIZER WIRE. UPON RETRIEVAL OF THE FILTER, THE FILTER DETACHED AND WAS LEFT IN THE VESSEL. TWO BALLOON EXPANDABLE STENTS WERE DEPLOYED, EMBEDDING THE FILTER UP AGAINST THE WALL OF THE VESSEL. TIMI FLOW OF 3 WAS ACHIEVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT DELAY IN PROCEDURE REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TROPONIN T RESULT FOR ONE PATIENT SAMPLE FROM THE CARDIAC READER IN THE EMERGENCY ROOM. THE INITIAL RESULT FROM THE ORIGINAL SAMPLE WAS 1.1 NG/ML AND WAS REPORTED. A SEPARATE SAMPLE DRAWN FROM THE PATIENT AT THE SAME TIME GAVE A RESULT OF <0.01 NG/ML FROM THE COBAS E601 ANALYZER. THE ORIGINAL SAMPLE WAS RETESTED ON (B)(6) 2010 WHICH WAS OUTSIDE THE SAMPLE STABILITY SPECIFIED IN PRODUCT LABELING AND THE RESULT WAS <0.03 NG/ML. THE PATIENT WAS ADMITTED AND HEPARIN THERAPY AND A NITROGLYCERIN DRIP WERE STARTED BUT DISCONTINUED ONCE THE COBAS E601 RESULT AND REPEAT RESULT FROM THE ORIGINAL SAMPLE WERE OBTAINED. THE PATIENT'S CURRENT CONDITION WAS "IMPROVING; PAIN SUBSIDING". NO FURTHER INFORMATION CONCERNING THE PATIENT WAS AVAILABLE. THE TROPONIN T REAGENT LOT NUMBER WAS 226624-41.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC READER CARDIAC READER SYSTEM MMI ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 CLARITIN| DETROL| GLUCOPHAGE| MOBIC| ACTOS