BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2221645 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04538
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 10, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE MOST LIKELY REASON FOR EVENT MIGHT BE THAT INSUFFICIENT SAMPLE VOLUME WAS PIPETTED DUE TO BUBBLES OR FOAM ON SAMPLE SURFACE OR TOO LOW A SAMPLE VOLUME. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LAB, THUS THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE HCG +SS RESULT FOR ONE PATIENT SAMPLE THAT WAS DISCOVERED DUE TO THE LABORATORY'S PROTOCOL TO REPEAT ALL SAMPLES WITH HCG +SS RESULTS BETWEEN 6 AND 100 MIU/ML. THE RESULT FROM THE FIRST ALIQUOT WAS 35.63 MIU/ML. THE RESULT FROM A SECOND ALIQUOT WAS 10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT FROM THE SECOND ALIQUOT WAS 10000 MIU/ML WITH A DATA FLAG. THE AUTOMATIC REPEAT RESULT WAS 29098 MIU/ML. THE REPEAT RESULT FROM THE INITIAL ALIQUOT WAS 10000 MIU/ML WITH A DATA FLAG. THE AUTOMATIC REPEAT RESULT WAS 28251 MIU/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THE RESULT OF 29098 MIU/ML WAS REPORTED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG +SS REAGENT LOT NUMBER WAS 16015003. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND SUSPECTED THE PATIENT SAMPLE. HE NOTED A POSSIBLE CAUSE WAS AIR BUBBLES IN THE SAMPLE. HE CHECKED THE CALIBRATION AND QUALITY CONTROL AND VERIFIED IT PASSED ACCORDING TO THE GUIDELINES. HE REPEATED THE PRIMARY SAMPLE WITH A RESULT OF 10000 MIU/ML WITH A DATA FLAG AND AN AUTOMATIC REPEAT RESULT OF 29587 MIU/ML. HE REPEATED AN ALIQUOT OF THE SAMPLE WITH A RESULT OF 10000 MIU/ML WITH A DATA FLAG AND AN AUTOMATIC REPEAT RESULT OF 28623 MIU/ML. HE DETERMINED THE ANALYZER WAS PERFORMING PROPERLY AND ADVISED THE USER TO CHECK THE SAMPLE INTEGRITY BEFORE TESTING. UPON FOLLOW UP, THE USER STATED HE NOTICED NO BUBBLES OR FOAM ON THE REAGENT OR SAMPLE.

    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