BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTEX SPS SPORVIEW CULTURE SET

    MDR report key: 7742284 · Received August 1, 2018

    Report

    Report Number
    MW5078765
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    June 27, 2018
    Report Date
    July 27, 2018
    Manufacturer
    CROSSTEX SPS MEDICAL
    Product Code
    MRB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPECIFICS ARE: CROSSTEX SPS SPORVIEW CULTURE SET. CAT NO. CS-020. LOT 580. VIALS IDENTIFIED IN 2 BOXES WITH SAME BATCH NUMBER. NUMBER OF VIALS THAT APPEAR CONTAMINATED: 5. ¿EXPIRATION APRIL 30, 2019. WHEN WE RECEIVED THE NEW BOX FROM OUR LOGISTICS, MANY OF THE SPORE TUBES WERE YELLOW OR LIGHT PURPLE WITH PRECIPITATE, INSTEAD OF THE NICE CLEAR PURPLE. THE CAPS ON THE VIALS APPEARED TO BE SECURE. THE VIALS THAT APPEAR TO BE CONTAMINATED APPEAR TO HAVE LESS LIQUID VOLUME IN THE VIALS. THERE ALSO APPEARS TO BE A SMALL QUARTER SIZE WATER SPOT ON THE BOXES (TOP BACK). THE CONCERN IS THAT THIS MAY RESULT IN A FALSE POSITIVE, ESPECIALLY IF CLINICS REPORT RECEIVE A CONTAMINATED SET BUT THE COLOR HASN'T CHANGED OR PRECIPITATE DETECTED. THESE VIALS WERE PROMPTLY REMOVED FROM OUR INSTRUMENT PROCESSING CENTER. A PHONE CALL WAS MADE TO CROSSTEX AT 1800-722-1529 TO REPORT THE INCIDENT. THEY RECOMMENDED TO EMAIL [email protected] ON JUNE 27, 2018, BUT THE EMAIL WAS REJECTED BY THE SERVER. ANOTHER EMAIL WAS SENT TO [email protected] ON JULY 9, 2018 AND ADDRESSED TO SPSMEDICAL QA, BUT NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580060 CROSSTEX SPS SPORVIEW CULTURE SET CROSSTEX SPS SPORVIEW CULTURE SET MRB CROSSTEX SPS MEDICAL SPS SPORVIEW CULTURE SET 580

    Patients

    Seq Age Sex Outcome Treatment
    1