BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGOXIN

    MDR report key: 2191961 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04208
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K973112
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF RESPONSE: IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE DIGOXIN RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON A MODULAR ANALYTICS P-MODULE, (B)(4). THE INITIAL DIGOXIN RESULT WAS 3.9 NG/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND RECOVERED 1.3 NG/ML (ACCOMPANIED BY A DATA FLAG). THE INITIAL DIGOXIN RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER CONSIDERED THE REPEAT RESULT TO BE CORRECT. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THE DISCREPANCIES. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND A SPECIFIC CAUSE OF THE DISCREPANCIES. HE REPLACED THE R1 STIRRER PADDLE, REACTION CELLS AND DI TUBING FOR NOZZLE #6. THE FIELD SERVICE REPRESENTATIVE ALSO CLEANED RINSE WELLS, PROBES AND RINSE MECHANISMS. HE CHECKED AND ADJUSTED RINSE MECHANISM LEVELS AND CHECKED THE GEAR PUMP PRESSURE. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROL. ALSO A PRECISION, USING DIGOXIN, WAS PERFORMED. ALL CHECKS AND TESTS WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS NA 59503352

    Patients

    Seq Age Sex Outcome Treatment
    1