BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM SURE-T

    MDR report key: 4260929 · Received October 16, 2014

    Report

    Report Number
    3003442380-2014-00090
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    July 24, 2014
    Report Date
    October 16, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CAPA ((B)(4)) INVESTIGATED STRENGTHENING THE NEEDLE AND BASED ON A DESIGN MODIFICATION, COULD INCREASE ITS RESILIENCE TO UNIFORM MOVEMENT. THESE PRODUCTS STARTED MFG IN MAY 2014.

    Description of Event or Problem · 1

    CUSTOMER'S MOM CALLED, STATED HER SON IS GOING TO BE (B)(6) AND HE IS USING THE SURE-T; BROKE OFF IN HIS BOTTOM AND HE WANTS TO KNOW WHAT TO DO. MOM STATES THAT HIS HCP TOLD HER TO HAVE AN X-RAY AND THE NEEDLE WAS BROKEN OFF IN THERE. MOM STATES THAT HE HAD THIS SURE-T ON FOR 3 DAYS AND WAS RUNNING HIGH BUT IT'S B/C THEY ARE ON VACATION AND THE FAMILY HAS BEEN GIVING HIM FOOD. EXPL TO MOM THAT SURE-T IS TO BE USED 2 DAYS. MOM STATES THAT HIS BLOOD GLUCOSE TODAY WAS 149 BUT THEN WENT UP TO 300 BUT SHE THINKS THEY MAY HAVE FORGOT TO BOLUS FOR LUNCH. ADV MOM SHE COULD TRY AND REMOVE THE NEEDLE W/ TWEEZERS BUT I WOULD RECOMMEND TO GO TO THE HCP TO HAVE IT REMOVED. ASKED MOM TO HANG ON TO THE SITE AND WHEN THE NEEDLE IS REMOVED THEN SEND ALL OF THAT I/S BACK TO US. ON (B)(4) 2014 CALLED FAMILY OF CUST TO FOLLOW UP ON OUTCOME OF NEEDLE BREAK. NO ANSWER. LEFT VOICEMAIL ON FILE W/ MY CONTACT DETAILS. ON (B)(4) 2014 CALLED FAMILY OF CUST. NO ANSWER. LEFT VOICEMAIL W/ MY CONTACT DETAILS. ON (B)(4) 2014 (B)(4) FROM CSC STATES THAT CUSTOMERS FATHER IS ON THE LINE AND STATES SON USES SURE-T AND NEEDLE BROKE INSIDE HIM WHILE HE WAS TRYING TO REMOVE IT, BROKE INSIDE HIM, HAD ON BACK SIDE. HIPPA CONFIRMED. (B)(6) DAD IS ON THE LINE. CUSTOMER STATES THIS HAPPENED ABOUT A MONTH AGO WENT CHANGE SONS INFUSION SET AND THE NEEDLE WAS BROKEN OFF AND LODGED INTO TISSUE ON LEFT BUTTOCK ABOUT AN INCH AND QUARTER IN AND HAD TO HAVE SURGERY TO REMOVE. ON (B)(6) 2014 MOTHER (B)(6) CALLED AND LEFT A VM RETURNING MY CALL. I CALLED (B)(6) BACK AND LEFT A MESSAGE TO CALL ME, PROVIDED MY CONTACT INFO. I THEN CALLED FATHER, (B)(6), I ADV HIM I CALLED (B)(6) AND LEFT HER A MESSAGE. I ASKED IF HE ENDED UP TAKING THE CUSTOMER TO THE HOSP. HE STATED HE DID. THE CUSTOMER WAS TAKEN TO (B)(6) ON (B)(6) 2014. HE WAS TAKEN TO THE URGENT CARE DEPT, NOT THE ER. THE NEEDLE WAS 7 MM IN THE SKIN. THE HCP SEDATED THE CUSTOMER AND WAS ABLE TO GET THE NEEDLE REMOVED WITHOUT ISSUE. FATHER STATED HE WAS GIVEN THEN NEEDLE BY THE HCP AND WILL RETURN THE NEEDLE WITH THE INFUSION SET. CONFIRMED THAT HE DOES HAVE THE RETURN PACKAGING AND THE RECEIVE ONLY ORDER IS SETUP TO RECEIVE THE RETURNING PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659773 PARADIGM SURE-T PARADIGM SURE-T FPA UNOMEDICAL A/S MMT-864 5057955

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention