BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 2781942 · Received October 3, 2012

    Report

    Report Number
    3003442380-2012-00019
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    June 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL (B)(4) HAS NOT RECEIVED ANY DEVICES. THE RETAIN SAMPLES FOR LOT NUMBERS ASSUMED USED BY CUSTOMER ARE TESTED ACCORDING TO SPECIFICATIONS. BASED ON TEST RESULTS FROM THE VISUAL TESTING, FLOW AND LEAK, THE RETAIN SAMPLES WERE WITHIN SPECIFICATIONS. EVALUATION SUMMARY, MFR REPORT# (B)(4): USED DEVICE: NO USED DEVICES WERE RETURNED FOR INVESTIGATION. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR INVESTIGATION. REFERENCE SAMPLES: 10 REFERENCE SAMPLES FROM EACH LOT WERE TESTED. LOT NUMBER / MANUFACTURING DATE / DEVIATION ON PACKING: #658048 / 11/27/2011 / NO DEVIATIONS FOUND ON PACKING. RETAINED SAMPLES WERE TESTED FOR VISUAL, FLOW TEST AND LEAK TEST FINDING ALL SAMPLES IN ACCORDANCE WITH SPECIFICATIONS, #658040 / 11/06/2011 / NO DEVIATIONS FOUND ON PACKING. RETAINED SAMPLES WERE TESTED FOR VISUAL, FLOW TEST AND LEAK TEST FINDING ALL SAMPLES IN ACCORDANCE WITH SPECIFICATIONS, 658039 / 11/06/2011 / NO DEVIATIONS FOUND ON PACKING. RETAINED SAMPLES WERE TESTED FOR VISUAL, FLOW TEST AND LEAK TEST FINDING ALL SAMPLES IN ACCORDANCE WITH SPECIFICATIONS, #658046 / 11/19/2011 / NO DEVIATIONS FOUND ON PACKING. RETAINED SAMPLES WERE TESTED FOR VISUAL, FLOW TEST AND LEAK TEST FINDING ALL SAMPLES IN ACCORDANCE WITH SPECIFICATIONS, #658047 / 11/27/2011 / NO DEVIATIONS FOUND ON PACKING. RETAINED SAMPLES WERE TESTED FOR VISUAL, FLOW TEST AND LEAK TEST FINDING ALL SAMPLES IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT A (B)(6) GIRL DIED (B)(6) 2012, AFTER BEING ON A VEO PUMP FOR A MONTH. SHE WAS USING A MODEL MMT-399 INSULIN INFUSION SET THAT WAS DISCARDED AT THE HOSPITAL. PATIENT WAS USING PUMP SINCE (B)(6) 2012. DIABETES BETTER MANAGED WITH THE PUMP THAN MDI USED BEFORE. THE PATIENT ALREADY DID A KETOACIDOSIS (B)(6), STILL WAS WITH MDI, CATHETER CHANGED (B)(6). BASED ON PARENTS DECLARATION, CHILD PRESENTED WITH NAUSEA AND VOMITING ON (B)(6), EVENING. THEY WENT TO HOSPITAL EMERGENCY DEPARTMENT ON (B)(6) IN THE MORNING. CHILD ARRIVED CONSCIOUS. CATHETER HAD BEEN REMOVED AT THAT MOMENT; IT SHOWED BENT CANNULA (MMT-399). PUMP NEVER ALARMED. BIOLOGICAL ANALYSIS IS DONE SHOWING KETOACIDOSIS AND HYPERKALEMIA. BY THE END OF MORNING, CHILD STATEMENT HAS RAPIDLY TAKEN A TURN FOR THE WORSE. CHILD DIED AT 13:35 PM BY HEART FAILURE, DESPITE RESUSCITATION SCHEME. INCIDENT TOOK PLACE IN: (B)(6). LOT NUMBER IS UNKNOWN, BUT COULD HAVE BEEN ONE OF THE FOLLOWING LOTS: 658048, 658040, 658039, 658046, 658047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-399 658048

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death