BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 4272291 · Received October 3, 2014

    Report

    Report Number
    3003442380-2014-00080
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    May 29, 2014
    Report Date
    October 3, 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, LEAK, AND VENTILATION TO THE PCC RESERVOIR CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICES (3). IN THE VISUAL INSPECTION FOUND THE SOFT CANNULA WAS KINKED ) AT THE MIDDLE 2, AT THE BASE PIECE AND THE FLOW TEST FOUND THE PCC CONNECTOR NEEDLE WAS CLOGGED (BY INSULIN 1/3). THE LEAK AND VENTILATION TESTS WERE IN ACCORDANCE WITH SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK, AND VENTILATION TO THE PCAP. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE SOFT CANNULA WAS KINKED IN 3 OF THE RETURNED DEVICES. DURING MFG OF THE CANNULA PART THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCED NEEDLE. HOWEVER IF THE INTRODUCER NEEDLE IS BENT DURING HANDLING AND PACKING OF THE INFUSION SET, THIS MAY AFFECT THE SOFT CANNULA CAUSING IT TO KINK. TO PREVENT SYSTEMATIC FAILURE DURING MFG, UNOMEDICAL USES ONLINE SAMPLE PLANS ACCORDING TO ISO 2859-1. SAMPLE SIZES ARE TESTED AGAINST SPECIFICATIONS. DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION THE PT MAY ACCIDENTALLY KINK THE SOFT CANNULA. UNOMEDICAL HAS INVESTIGATED THE ORIGINS OF KINKED SOFT CANNULA AND FOUND NO MATERIAL OR PROCESS ORIGINS. UNOMEDICAL A/S CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 1

    INITIALLY THE PT EXPLAINS THAT HE EXPERIENCED A HYPOGLYCAEMIC EVENT AND TREATED WITH GLUCOSE TABLETS AND FOOD. HE HAD BEEN EXPERIENCING SOME NO DELIVERY ALARMS ALSO NOTICED THAT THE SOFT CANNULA OF THE INFUSION SET WERE BENT (4). INITIAL NOTES: CUSTOMER STATES THAT HE HOSPITALIZED LAST THURSDAY (B)(6) 2014 DUE TO HIGH BGS. CUSTOMER STATES THAT HE WAS RUNNING HIGH DUE TO THE RESERVOIR AND INFUSION SET WERE NOT LOCKED TOGETHER CORRECTLY AND CUSTOMER WAS NOT RECEIVING INSULIN. BT THE TIME CUSTOMER REALIZED THAT THE RESERVOIR WAS NOT CONNECTED CORRECTLY HE WAS RUNNING A HIGH BG AND WAS DEHYDRATED. CUSTOMER STATES THAT THERE WAS AN EMERGENCY ROOM VISIT FOR THEIR HIGH BGS. TIME AND DATE OF EMERGENCY ROOM VISIT WAS: (B)(6) 2014, 9:30 PM. BG AT THE TIME OF EMERGENCY ROOM VISIT WAS: 560. NAME OF THE HOSP: (B)(6). NAME OF INDIVIDUAL REPORTING THE INCIDENT: SELF. PHONE NUMBER OF THE REPORTER OR HOSP: (B)(6). DESCRIPTION OF THE COMPLAINT: HIGH BG. SIGNIFICANT EVENTS LEADING TO THE EMERGENCY ROOM VISIT: CUSTOMER WAS TOO DEHYDRATED AND CUSTOMER ATTEMPTED TO TREAT WITH PUMP BUT CUSTOMER WAS VERY DEHYDRATED. PT WAS NOT IN AN ACCIDENT. CAUSE OF EMERGENCY ROOM VISIT AS PER HCP: HIGH BG. OUTCOME OF THE EMERGENCY ROOM VISIT: INSULIN DRIP AND FLUIDS THROUGH IV. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF EMERGENCY ROOM VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617606 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-397 5050488

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention