BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3474982 · Received November 18, 2013

    Report

    Report Number
    1056600-2013-00071
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 18, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS MOST LIKELY CAUSED BY THE FACT THAT THE CUSTOMER DID NOT CENTRIFUGE THE SAMPLES PRIOR TO BEING LOADED ON THE PROVUE. THE OPERATOR ALSO MODIFIED THE NRD RESULT ISSUED BY THE PROVUE FOR THE WELL THAT THE CUSTOMER REPORTED WAS UNDER-DISPENSED AND ENTERED A NEGATIVE RESULT. PRIOR TO CONTACTING CTS, CUSTOMER TESTED THE SAME SAMPLE ON THEIR OTHER PROVUE, (B)(4) AND THE EXPECTED 2+ REACTION WAS OBTAINED. THIS WAS A KNOWN SAMPLE THAT WAS BEING USED AS QC MATERIAL IN THIS CASE, BUT THIS USER OVERSIGHT OF MODIFYING AN NRD RESULT ON THE PROVUE COULD HAVE AFFECTED PATIENT TESTING IF IT WERE TO REOCCUR. THE DEVICE WAS PERFORMING AS INTENDED BY ISSUING AN NRD RESULT. THE OPERATOR BYPASSED THE FAILSAFE OF THE DEVICE DESIGNED TO PREVENT THE CREATION OF AN ERRONEOUS RESULT BY MANUALLY ENTERING A NEGATIVE RESULT FOR A KNOWN 2+ SAMPLE. THERE WAS NO HARM TO ANY PATIENT. QUALITY CONTROL TESTING PERFORMED BEFORE AND AFTER THIS EVENT PASSED. THERE WAS NO REPORTED HARM TO ANY PATIENTS. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; BUT WAS USED IN A WAY THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE EVENT WERE TO RECUR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE PROVUE'S PROBE IS NOT DISPENSING THE APPROPRIATE AMOUNT OF CELLS FOR DAT TESTING. A DAT POSITIVE QC SAMPLE WAS TESTED AND A FALSE NEGATIVE REACTION WAS OBTAINED. PRIOR TO CONTACTING CTS, CUSTOMER TESTED THE SAME SAMPLE ON THEIR OTHER PROVUE, (B)(4) AND THE EXPECTED 2+ REACTION WAS OBTAINED. CUSTOMER NOTED THE AMOUNT OF CELLS THAT WERE DISPENSED INTO THE GEL CARD WAS INADEQUATE IN THAT THE NEGATIVE CELL BUTTON WAS HALF THE SIZE CUSTOMER IS ACCUSTOMED TO SEEING IN THE MICROTUBE. ISSUE STARTED ON: (B)(6) 2013, FREQUENCY: ONCE, ERROR OCCURRED DURING: QC TESTING. CUSTOMER REPORTS ALL CAPS AND CONNECTORS WERE SECURE, A RINSE WAS DONE AND NO CLOTS WERE EXTRACTED FROM THE DILUTION CUP. CUSTOMER STATES THE SAMPLES ARE NOT CENTRIFUGED PRIOR TO BEING LOADED ON THE PROVUE. CTS DISCUSSED THE IMPORTANCE OF DOING SO AND CUSTOMER AGREES THE SAMPLE WILL BE RETESTED DURING THE NEXT SHIFT. CTS REQUESTED THE PRINTOUT SHOWING THE NEGATIVE RESULT BE FAXED TO CTS. CUSTOMER STATES SHE WILL DO SO. CTS FOLLOWED UP WITH CUSTOMER REQUESTING FOR STATUS OF QC TESTING. CUSTOMER REPORTS THE DAT PASSED AND THE RESULT WAS 3+. CUSTOMER CONFIRMED THE SAMPLE WAS SPUN BEFORE RETESTING. CUSTOMER IS SATISFIED THE RESULT WAS AS EXPECTED. CTS REVIEWED THE FAX AND CUSTOMER CONFIRMS THERE WAS NRD THAT WAS ISSUED BY THE PROVUE AND THE RESULT WAS MANUALLY MODIFIED TO NEGATIVE BY THE ORIGINAL CALLER. (B)(4) 2013: CTS CONTACTED CUSTOMER FOR FOLLOW UP. CUSTOMER STATES THE PROVUE IS WORKING AS EXPECTED. CUSTOMER REQUESTED FEEDBACK FROM OTHER OPERATORS THAT USE THE PROVUE AND THEY TOO STATE IT IS WORKING AS EXPECTED. CUSTOMER AGREES TO CONTACT CTS IF ISSUES ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597067 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS MTS213784

    Patients

    Seq Age Sex Outcome Treatment
    1