BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNA PURE24 INSTRUMENT

    MDR report key: 7325066 · Received March 8, 2018

    Report

    Report Number
    2243471-2018-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 8, 2018
    Report Date
    May 10, 2018
    Manufacturer
    STACIE-ANN CREIGHTON
    Product Code
    JJH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION OF A NEW PROTOCOL, AN EXTERNAL COLLABORATOR IDENTIFIED CROSS-CONTAMINATION OF SAMPLES WHEN RUNNING THE EXISTING PATHOGEN200 PROTOCOL ON THE MAGNA PURE 24 SYSTEM. THE INTERNAL INVESTIGATION HAS CONFIRMED THE ISSUE FOR THE LAUNCHED PATHOGEN200 AND PATHOGEN1000 PROTOCOLS. THE CROSS-CONTAMINATION OF SAMPLES DURING PATHOGEN NUCLEIC ACID EXTRACTION CAN CREATE FALSE POSITIVE OR OVER-QUANTIFIED RESULTS. FALSE POSITIVE OR OVER-QUANTIFIED RESULTS MAY RESULT IN EXPOSURE TO UNNECESSARY MEDICATION SIDE EFFECTS OR MEDICAL PROCEDURES THAT HAVE A REMOTE PROBABILITY OF CREATING ADVERSE HEALTH CONSEQUENCES. CUSTOMERS WERE INFORMED OF THIS SITUATION AND POTENTIAL SAFETY RISKS. ADDITIONALLY, UPDATED PATHOGEN200 AND PATHOGEN1000 PROTOCOLS WILL BE AVAILABLE WITHIN THE NEXT 2-3 MONTHS. CAPA WAS INITIATED AND CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE UDI FOR THE MAGNA PURE 24 INSTRUMENT IS (B)(4), AND THE INSTRUMENT IS 501K EXEMPT.

    Description of Event or Problem · 1

    DURING INVESTIGATION OF A NEW PROTOCOL, AN EXTERNAL COLLABORATOR IDENTIFIED CROSS-CONTAMINATION OF SAMPLES WHEN RUNNING THE EXISTING PATHOGEN200 PROTOCOL ON THE MAGNA PURE 24 SYSTEM, WHEN USING THE RACK-BASED PURIFICATION RUN. THE CUSTOMER IS UTILIZING STOOL SAMPLES CONTAINING HIGH TITER NOROVIRUS AND ROTAVIRUS, AND KNOWN NEGATIVE SAMPLES ARE GENERATING CP VALUES. NO HARM OR INJURY OCCURRED. RESULTS GENERATED HAVE NOT BEEN USED FOR DIAGNOSTIC PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167941 MAGNA PURE24 INSTRUMENT CLINICAL SAMPLE CONCENTRATOR JJH STACIE-ANN CREIGHTON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1