BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1695293 · Received May 20, 2010

    Report

    Report Number
    1823260-2010-03106
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    April 22, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE FROM THE PATIENT WAS RETURNED FOR INVESTIGATION. THE RESULTS FROM THE ELECSYS WERE VERIFIED. DILUTION MEASUREMENTS CLEARLY IDENTIFIED AN INTERFERENCE IN THE SAMPLE. FURTHER INVESTIGATION COULD NOT DETECT INTERFERENCE AGAINST RUTHENIUM OR AGAINST STREPTAVIDIN SOLID PHASE. THERE WAS THE POSSIBILITY OF AN ANTI-IDIOTYPE OR ANTI-DIGOXIN INTERFERENCE, HOWEVER, DUE TO THE INSUFFICIENT SAMPLE VOLUME, FURTHER INVESTIGATION WAS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED SEEING A SPARK FROM THE DOOR AREA OF THE STERILIZER. NO INJURIES WERE REPORTED TO PATIENTS OR HOSPITAL STAFF.

    Description of Event or Problem · 1

    ANOTHER FACILITY HAD A PATIENT SAMPLE RESULT IN THE CRITICAL RANGE FOR DIGOXIN THEN NORMAL ON A SEPARATE SAMPLE. THE INITIAL SAMPLE WAS SENT TO THIS FACILITY AND TESTED ON (B) (6) 2010 ON THE (B) (6) 2010, ANALYZER WITH A RESULT OF >5.0NG/ML WITH A DATA FLAG, REPEATED WITH A 1:2 DILUTION RESULTED AS 8.47 NG/ML. THE INITIAL RESULT FROM THE (B) (4) ON (B) (6) 2010 AT THE INITIAL FACILITY WAS >5.0 NG/ML, REPEAT RESULT ON (B) (6) 2010 WAS >5.0 NG/ML AND WITH A 1:2 DILUTION WAS 8.21 NG/ML. ON (B) (6) 2010, THE PATIENT WAS SENT TO THE ER AND SAMPLE DRAWN THERE RESULTED AS 0.86 NG/ML ON THE BECKMAN DXC 600I. THAT SAMPLE WAS REPEATED FOR CONFIRMATION (B) (6) 2010 ON THE DXC 600 ANALYZER AND RESULTED 0.92 NG/ML. A SEPARATE SAMPLE DRAWN AT THE SAME TIME AS THE INITIAL WAS TESTED ON (B) (6) 2010 ON THE DXC 600 ANALYZER WITH A RESULT OF 1.83 NG/ML. THAT SAME SAMPLE WAS TESTED ON THE BECKMAN DXC 600I WITH A RESULT OF 1.65 NG/ML. THE INITIAL SAMPLE WAS SENT TO ANOTHER HOSPITAL FOR TESTING ON (B) (6) 2010 WITH RESULTS OF 1.5, 1.4 AND 1.4 NG/ML. THE ERRONEOUS RESULT WAS REPORTED. NO TREATMENT WAS PROVIDED BASED ON THE ERRONEOUS RESULT. THE DIGOXIN REAGENT LOT NUMBER WAS 15406001. THE USER DECLINED A SERVICE VISIT STATING THEY DO NOT BELIEVE THEY ARE HAVING A PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR