BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 4036943 · Received June 24, 2014

    Report

    Report Number
    3003442380-2014-00055
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    January 28, 2014
    Report Date
    June 23, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED DEVICES. THE SOFT CANNULA WAS KINKED AT THE TIP, ON ONE OUT OF TWO ALSO THE PCC CONNECTOR NEEDLE WAS CLOGGED BY INSULIN ON BOTH SAMPLES. THE LEAK TEST WAS FOUND WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DURING MFG OF THE CANNULA PART THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCER NEEDLE; HOWEVER, IF THE INTRODUCER NEEDLE IS BENT DURING HANDLING AND PACKAGING OF THE INFUSION SET, THIS MAY AFFECT THE SOFT CANNULA CAUSING IT TO KINK. TO PREVENT SYSTEMATIC FAILURES DURING MFG, UNOMEDICAL USES ONLINE SAMPLING PLANS ACCORDING TO ISO 2859-1. SAMPLE SIZES ARE TESTED AGAINST SPECIFICATIONS. DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION THE PATIENT MAY ACCIDENTALLY KINK THE SOFT CANNULA. THIS REPORT HAS ALREADY BEEN REPORTED TO FDA IN THE ASR IN Q1 2014, AT THAT TIME WE DID NOT KNOW IF ANYTHING WAS WRONG WITH THE INFUSION DEVICE. UNOMEDICAL A/S HEREBY CONSIDERS THIS CASE TO BE CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 INITIAL NOTES: MY DAUGHTER JUST RECEIVED THE PUMP A FEW WEEKS AGO AND IS HAVING TROUBLE WITH THE QUICK SET INFUSION SETS; THEY HAVE BEEN BENT. THE CANNULA HAVE BEEN BENT AND THE TUBING HAS BEEN BENT ALSO SINCE (B)(6) 2014. PATIENT HAS TREATED WITH THE PUMP A CORRECTION BUT STILL 451 NOW SHE IS DOING MANUAL INJECTIONS. THE SET THEY REMOVED OF HER BODY SEEMED KINKED. ASSISTANCE PROVIDED: ADVICE. I WOULD SEND THE REPLACEMENTS FOR HER, OVERNIGHT AS SHE IS ALL OUT OF SETS NOW. PATIENT'S MOM DID STATE THAT SHE HAS ALREADY SPOKEN TO DOCTOR AND WANTS TO TRY DIFFERENT LOT. ADVICE: IF CONTINUES TO HAPPEN, CALL US BACK TO POSSIBLY LOOK INTO DIFFERENT TYPES OF SETS TO TRY, LAST SET THAT CAME OUT WAS KINKED AND DAUGHTER IS NOW ON MANUAL INJECTIONS. PATIENT DECLINED HIGH BG TROUBLE SHOOTING AND WILL WAIT TO SEE IF THE NEW SETS WORK OUT. SHE ALSO STATED THAT HER DOCTOR MADE SOME ADJUSTMENTS AS WELL SO THEY WILL WAIT TO SEE IF IT WORKS. ADVICE TO CALL US BACK IF PATIENT WAS STILL RUNNING HIGH OR IF BENT CANNULAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368555 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-399 5044200

    Patients

    Seq Age Sex Outcome Treatment
    1