BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX SP-1000I

    MDR report key: 3640823 · Received February 6, 2014

    Report

    Report Number
    3009711478-2014-00005
    Event Type
    Injury
    Date Received
    February 6, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE WAS PROVIDED TO SUGGEST THAT AN ACTUAL DEVICE FAILURE OCCURRED OR THAT THE DEVICE FAILED TO PERFORM WITHIN SPECIFICATIONS. THE USER REPORTED THE SAMPLE BECAME STUCK FOR AN UNKNOWN REASON AND INTERVENED TO PREVENT AN ERROR FROM OCCURRING.

    Description of Event or Problem · 1

    THE USER OF A SP-1000I AUTOMATED SLIDE PREPARER REPORTED ON (B)(6) 2014 THAT THE INSTRUMENT'S CAP PIERCER STUCK A USER'S HAND. THE USER NOTED THAT A SAMPLE TUBE HAD BECOME STUCK IN THE TUBE CLAMP, WHICH PICKS UP THE TUBE FROM THE SAMPLE RACK AND DELIVERS IT TO BE MIXED AND TO THE CAP PIERCER. THE USER ATTEMPTED TO REMOVE THE TUBE THAT WAS STUCK WHILE THE INSTRUMENT WAS IN OPERATION DURING THE RINSE SEQUENCE. THE USER SAW A PHYSICIAN AFTER THE EVENT, ALTHOUGH THE SPECIFIC TREATMENT WAS NOT PROVIDED. THE USER STATED THAT THE BLOOD THAT WAS SAMPLED DID NOT CONTAIN BLOOD BORNE PATHOGENS, SO THE PHYSICIAN DID NOT REQUIRE ANTI-VIRAL PROPHYLAXIS. THE SITE'S INTERNAL POLICY FOR NEEDLE STICKS WAS FOLLOWED. RESULTS OF TESTING FROM THE OPERATOR OR THE SOURCE FOR (B)(6) WERE NOT PROVIDED. THIS POLICY WAS REQUESTED ON MULTIPLE OCCASIONS, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78375 SYSMEX SP-1000I AUTO HEMATOLOGY SILDE PREPARATION UNIT GKZ SYSMEX CORPORATION SP-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other