BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 4272544 · Received October 9, 2014

    Report

    Report Number
    3003442380-2014-00081
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    February 24, 2014
    Report Date
    October 9, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFT CANULA WAS KINKED. DURING MANUFACTURING OF THE CANNULA PART OF 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. DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION THE PATIENT MAY ACCIDENTALLY KINK THE SOFT CANNULA. USED DEVICE: A VISUAL INSPECTION AND TESTS FOR FLOW LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICES (1 TUBING AND 9 SETS). SOFT CANNULAS WERE KINKED (AT THE TIP) (5/10)' AND PCC CONNECTOR NEEDLE WERE CLOGGED (BY INSULIN) (7/10). LEAK AND VENTILATION TO PCC CONNECTOR TEST RESULTS WERE WITHIN SPECIFICATIONS. UNUSED DEVICES: A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED UNUSED DEVICES (10 SETS). ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014 CUSTOMER STATES THAT THERE WAS A EMERGENCY ROOM VISIT FOR THEIR HIGH BGS. TIME AND DATE OF ER VISIT WAS (B)(6) 2014 AT 9PM. NAME OF THE HOSPITAL: (B)(6) HOSPITAL. BLOOD GLUCOSE AT TIME OF ER VISIT WAS: 310. NAME OF INDIVIDUAL REPORTING THE INCIDENT: CUSTOMER. DESCRIPTION OF THE COMPLAINT: HIGH BLOOD GLUCOSE. SIGNIFICANT EVENTS LEADING TO THE ER VISIT: VOMITING, NAUSEA, EXCESSIVE THIRST. PATIENT WAS NOT IN AN ACCIDENT. CAUSE OF EMERGENCY ROOM VISIT AS PER HCP: SEVERE DKA, HBG, AND KIDNEY INFECTION. OUTCOME OF THE EMERGENCY ROOM VISIT: IV DRIP. ADDITIONAL INFORMATION: CUSTOMER WAS WEARING THE PUMP AT THE TIME OF EMERGENCY ROOM VISIT. CUSTOMER STATED THE PUMP DID NOT ALARM THAT IT WAS HAVING PROBLEMS DELIVERING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634815 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-399 5038940

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR