BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1833995 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05427
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 17, 2010
    Report Date
    February 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. IT WAS DETERMINED THE SAMPLE CONTAIN AN INTERFERING FACTOR TO THE IDIOTYPE OF ONE OF THE ANTIBODIES USED IN THE ASSAY. MOST LIKELY THIS INTERFERING FACTOR CAUSED THE ERRONEOUS DIGOXIN RESULTS. NO ADVERSE EVENTS IN RELATION TO THE EVENT WERE REPORTED. THE CONFIRMED INTERFERENCE IS COVERED BY A DISCLAIMER IN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    THE DIGOXIN REAGENT LOT NUMBER WAS 156250.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, FORESHORTENING OCCURRED. THE LESION WAS LOCATED IN A LEFT MAIN ARTERY. AN UNKNOWN PROMUS ELEMENT STENT WAS DEPLOYED IN THE LESION. THE PHYSICIAN NOTED THAT THE DEVICE 'SHORTENED MORE THAN IT SHOULD HAVE.' THE STENT COVERED THE LESION AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    A CUSTOMER RECEIVED QUESTIONABLE DIGOXIN RESULTS FOR ONE PATIENT. THE CUSTOMER PROVIDED 25 DIGOXIN RESULTS FOR THIS PATIENT. THE FOLLOWING 4 DIGOXIN SAMPLES WERE DISCREPANT WHEN REPEATED: SAMPLE 1, INITIAL RESULT, TESTED ON THIS ANALYTICAL E MODULE, WAS 1.5 NMOL/L. THE SAME SAMPLE REPEATED ON A SIEMENS ADVIA 1800 ANALYZER GAVE 0.0 NMOL/L. SAMPLE 2, INITIAL RESULT, TESTED (B)(6) 2010 ON THIS ANALYTICAL E MODULE, WAS 1.5 NMOL/L. THE SAME SAMPLE REPEATED ON A SIEMENS ADVIA 1800 ANALYZER GAVE 0.0 NMOL/L. SAMPLE 3, INITIAL RESULT, TESTED (B)(6) 2010 ON THIS ANALYTICAL E MODULE, WAS 1.5 NMOL/L. THE SAME SAMPLE REPEATED ON A SIEMENS ADVIA 1800 ANALYZER GAVE 0.0 NMOL/L. SAMPLE 4, INITIAL RESULT, TESTED (B)(6) 2010 ON THIS ANALYTICAL E MODULE, WAS 1.4 NMOL/L. THE SAME SAMPLE REPEATED ON A SIEMENS ADVIA 1800 ANALYZER GAVE 0.0 NMOL/L. THE PATIENT HAD STOPPED TAKING DIGOXIN ON (B)(6) 2010. THE INITIAL DIGOXIN RESULTS WERE REPORTED. THE PATIENT WAS NOT AFFECTED. THE DIGOXIN REAGENT LOT NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR