BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1650335 · Received April 5, 2010

    Report

    Report Number
    1823260-2010-02013
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    March 11, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    A FAILED PERFORMANCE TEST WAS OBSERVED DURING INVESTIGATION OF THE INSTRUMENT WHICH MEANS A HARDWARE ISSUE MIGHT HAVE CAUSED THE INCONSISTENT RESULTS. PRE-ANALYTIC DATA WAS NOT AVAILABLE THEREFORE PRE- ANALYTICS COULD NOT BE COMPLETELY EXCLUDED. SERVICE ACTIONS INCLUDING CHANGING CELL AND SAMPLE PIPETTE WERE PERFORMED DURING THE CUSTOMER VISIT. THERE WAS NO PATIENT INFORMATION PROVIDED. IT IS UNKNOWN WHY THE BETA- HCG TEST WAS PERFORMED AND IF THE FALSE RESULT WAS REPORTED OUTSIDE OF THE LAB. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A LAPAROSCOPIC RIGHT COLECTOMY PROCEDURE, THE DEVICE FIRED PROPERLY. HOWEVER, THE PATIENT'S ABDOMEN WAS DISTENDED AND POST OP THE SIXTH DAY, THE PATIENT BECAME TACHYCARDIC. THE PATIENT WAS RE-OPERATED WHERE IT WAS NOTICED TO HAVE SUBSTANCE AROUND THE ANASTOMOSIS. THERE WAS A LEAK AT THE DISTAL END OF THE TLC55 STAPLE LINE WHERE IT INTERSECTED AT THE TL60 MID STAPLE LINE. THE PATIENT WAS GIVEN A TEMPORARY COLOSTOMY AND IS STILL IN THE HOSPITAL.

    Description of Event or Problem · 1

    CUSTOMER HAD ON-GOING ISSUE WITH INCONSISTENT RESULTS. CUSTOMER PROVIDED ONE PATIENT EXAMPLE FOR BETA-HCG. FIRST BETA-HCG RESULT WAS 0.329, REPEAT 1213 U/L (ACCOMPANIED BY H DATA FLAG). REAGENT LOT # WAS 155484. IT IS UNKNOWN IF RESULT WAS REPORTED OR PATIENT WAS ADVERSELY AFFECTED DUE TO ERRONEOUS RESULT. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1