BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1873715 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06190
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DATA PROVIDED REVEALED THE SAMPLES AT THE CUSTOMER SITE ARE HANDLED MANUALLY. THE CUSTOMER MANUALLY POURS PATIENT SAMPLES FROM THE PARENT SAMPLE TUBES INTO LABELED ALIQUOT TUBES. THEREFORE HUMAN ERROR IN THE PROCESS OF DISPENSATION WAS INDICATED AS THE MOST LIKELY REASON FOR THE LOW RESULTS. NO INDICATION OF AN INSTRUMENT ISSUE WAS NOTED. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE REAGENT LOT NUMBER FOR FREE T4 WAS 157677. THE REAGENT LOT NUMBER FOR TSH WAS 156978.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR THYROTROPIN (TSH) AND FREE THYROXINE (FT4) ON THE ADDITIONAL E MODULE (E2) ANALYZER. THE USER ONLY PROVIDED RESULTS FOR ONE PATIENT SAMPLE WHICH WERE DISCREPANT, BUT SAID THERE MAY HAVE BEEN 3 OR 4 OTHER PATIENT SAMPLES INVOLVED IN THE EVENT. THE PATIENT SAMPLE WAS RUN FROM AN ALIQUOT OF THE ORIGINAL PRIMARY SAMPLE TUBE. THE INITIAL TSH RESULT GAVE 0.011 UIU/ML. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAME ALIQUOT WAS REPEATED ON ANOTHER E MODULE (E1) YIELDING A TSH RESULT OF 0.012 UIU/ML. THE INITIAL FT4 RESULT GAVE 0.298 NG/DL. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAME ALIQUOT WAS REPEATED ON ANOTHER E MODULE (E1) YIELDING A FT4 RESULT OF 0.275 NG/DL. THE REPEAT TSH AND FT4 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER SAID THE PHYSICIAN CALLED THE LABORATORY ON (B)(6) 2010 AND QUESTIONED THE LOW TSH AND FT4 RESULTS REPORTED FOR THIS PATIENT. THE ORIGINAL SAMPLE TUBE WAS PULLED AND ANOTHER ALIQUOT FROM THIS SAMPLE WAS RUN YIELDING A TSH RESULT OF 2.74 UIU/ML AND FT4 RESULT OF 1.36 NG/DL. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THIS EVENT. NO REAGENT LOT NUMBERS WERE PROVIDED FOR TSH OR FT4. THE USER DECLINED A FIELD SERVICE DISPATCH AS IT HAD BEEN ALMOST 4 WEEKS SINCE THIS EVENT OCCURRED ON (B)(6) 2010 AND THEY HAVE NOT BEEN ANY FURTHER EVENTS SINCE THAT DAY.

    Description of Event or Problem · 1

    ON (B)(6) 2006, A SMALL TYPE II ENDOLEAK WAS NOTED WITH NO ANEURYSM GROWTH. ON (B)(6) 2007, THE ENDOLEAK PERSISTED WITH NO ANEURYSM GROWTH. ON (B)(6) 2007, THE TYPE II ENDOLEAK PERSISTED WITH NO ANEURYSM GROWTH. ON (B)(6) 2008, THE TYPE II ENDOLEAK PERSISTED AND THE ANEURYSM GREW IN SIZE FROM 5.6 CM TO 6.3 CM. ON (B)(6) 2009, THE TYPE II ENDOLEAK PERSISTED AND THE ANEURYSM GREW TO 6.6 CM. ON (B)(6) 2009, THE TYPE II ENDOLEAK PERSISTED AND THE ANEURYSM SAC GREW TO 7.2 CM. IN (B)(6) 2009, THE PATIENT'S CARE WAS TRANSFERRED TO ANOTHER PHYSICIAN.

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL LAPAROSCOPIC HERNIA REPAIR. ACCORDING TO THE RPTR: THE BALLOON RUPTURED DURING THE CASE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PT. NO ADDITIONAL BLEEDING AND NO TISSUE DAMAGE WERE REPORTED. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1