BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1580289 · Received January 15, 2010

    Report

    Report Number
    1823260-2010-00275
    Event Type
    Injury
    Date Received
    January 15, 2010
    Date of Event
    December 27, 2009
    Report Date
    June 8, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K953239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES FROM THE PATIENT WERE RETURNED FOR INVESTIGATION. IT WAS DETERMINED THE ISSUE WAS RELATED TO NON-SPECIFIC AGGLUTINATION CAUSED BY AN UNIDENTIFIED FACTOR PRESENT IN THE PATIENT SAMPLE. NO DEVICE MALFUNCTION WAS IDENTIFIED. THE LIMITATIONS-INTERFERENCE SECTION OF THE PACKAGE INSERT FOR THE DIGOXIN ASSAY DOCUMENTS THE POTENTIAL FOR FALSELY LOW RESULTS RELATED TO NON-SPECIFIC AGGLUTINATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED FALSE LOW DIGOXIN RESULTS FOR ONE PT. THE DIGOXIN RESULT WAS LESS THAN 0.2 NG PER ML FOR SEVERAL BLOOD SAMPLES FROM THE SAME PT OVER SEVERAL DAYS. CUSTOMER CONFIRMED THE PT IS TAKING DIGOXIN IN NORMAL DOSES. THE SAMPLE WAS ALSO MEASURED IN TWO OTHER LABORATORIES USING AN IMX. THE DIGOXIN RESULT FROM EACH OF THESE LABORATORIES USING THE IMX WAS 2.9 NG PER ML. THE PT DEVELOPED DIGOXIN TOXICITY ("INTOXICATION") WITH VOMITING AND MEDICATION TREATMENT WAS CHANGED TO CORDARONE. NO ADD'L INFO WAS PROVIDED REGARDING THE PT. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(4) THAT THE DUAL LATCH SIDERAILS WERE NOT LATCHING. NO ADVERSE CONSEQUENCES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE KXT ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CLEXANE| FOLAVIT| BACTRIM| ARANESP| AUGMENTIN| DIGOXIN| BENDAMUSTINE| PANTOMED| MOVICOL| MOTILIUM| STILNOCT| ZOVIRAX