BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3324977 · Received September 4, 2013

    Report

    Report Number
    1823260-2013-05428
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Date of Event
    August 6, 2013
    Report Date
    December 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MRG
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE DATE OF THIS EVENT WAS (B)(6) 2013. THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT AFFECTED OR HARMED BY THIS EVENT.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE WAS NO PATIENT SAMPLE AVAILABLE FOR INVESTIGATION. THE CALIBRATION, QUALITY CONTROL, AND PRECISION WERE ACCEPTABLE. A REAGENT OR INSTRUMENT ISSUE WAS NOT LIKELY. A GENERAL INTERFERENCE FROM THE PATIENT'S KAHLER'S DISEASE WAS NOT LIKELY DUE TO THE ALKALINE PRE- TREATMENT IN THE METHOD.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE 25-HYDROXYVITAMIN D (VITD) RESULTS FOR ONE PATIENT ON THEIR E-MODULE. THE CUSTOMER STATED THAT A PATIENT WAS TESTED FOR VITD TWO DAYS ON A ROW. THE CUSTOMER STATED THEY HAD NO OTHER PROBLEMS WITH OTHER PATIENTS' SAMPLES. THE RESULT FROM THE FIRST SAMPLE WAS 13. THE RESULT FROM THE SECOND SAMPLE THE NEXT DAY WAS 67. AFTER SEEING THIS DIFFERENCE, THE CUSTOMER DECIDED TO REPEAT BOTH SAMPLES. THE FIRST SAMPLE WAS RETESTED AND THE RESULTS WERE 72.32, 43.64, AND 54.17. THE SECOND SAMPLE WAS RETESTED AND THE RESULTS WERE 58.46, 20.21, AND 31.05. AFTER THIS, BOTH SAMPLES WERE SENT TO ANOTHER LABORATORY AND TESTED USING HPLC. THE FIRST SAMPLE'S HPLC RESULT WAS 34. THE SECOND SAMPLE'S HPLC RESULT WAS 36. THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE VITD REAGENT LOT NUMBER WAS 171102. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438357 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER MRG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1