BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 3940672 · Received June 26, 2014

    Report

    Report Number
    3003442380-2014-00057
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    March 19, 2014
    Report Date
    June 26, 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

    THIS IS AN ONGOING INVESTIGATION. A FOLLOW UP OR FINAL MDR WILL BE SUBMITTED NO LATER THAN (B)(6) 2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014 CUSTOMER ADVICE THAT THREE MONTHS AGO, SHE WENT INTO DKA AND LOST HER BABY. ADVICE THAT WHEN THEY TOOK OUT THE CANNULA AT THE HOSPITAL, THE CANNULA WAS BENT BUT THE PUMP DIDN'T ALARM NO DELIVERY. APOLOGIZED FOR HER LOSS AND DISCUSSED WHY THE PUMP MIGHT HAVE NOT ALARMED NO DELIVERY. EXPLAIN THE "GARDEN HOSE" CONCEPT AND ADVICE THAT THE INSULIN MIGHT HAVE NOT BEEN ABSORBED IN THE SITE. EXPLAIN THAT HER BGS ARE THE BEST INDICATOR OF IF A SITE IS WORKING. EXPLAIN THAT WE CAN TROUBLE SHOOT THE PUMP FOR LACK OF A NO DELIVERY ALARM. CUSTOMER ADVICE SHE HAS HIGH BGS FROM A NO DELIVERY LAST NIGHT AS WELL. BG WAS 550, SHE GOT A NO DELIVERY AND SHE TOOK THE SITE OUT AND IT WAS A BENT CANNULA AS WELL. CONFIRMED SHE DID THE RIGHT THING BY FOLLOWING THE TWO HIGH BG RULE AND CHECKING HER SITE. CONFIRMED BGS ARE BEST INDICATOR FOR SITE HEALTH/FUNCTIONALITY. CUSTOMER WAS DRIVING AND DIDN'T HAVE THE TUBING CLAMP TO TROUBLE SHOOT, SO ADVICE HER THAT I CAN OVERNIGHT IT TO HER. EXPLAIN THAT ONCE SHE GOT IT, WE COULD TALK ABOUT DOING THE TROUBLE SHOOT FOR THE ABSENCE OF NO DELIVERY AND WE CAN DISCUSS THE SITES/SETS SHE IS USING TO AVOID GETTING ADDITIONAL BENT CANULAE. CUSTOMER WAS ABLE TO SHARE SOME DETAILS OF THE HOSPITALIZATION: CUSTOMER STATES THAT THERE WAS A ER VISIT FOR THEIR HIGH BGS. TIME AND DATE OF ER VISIT WAS: (B)(6) - 3PM. BG AT TIME OF ER VISIT WAS: 350. NAME OF THE HOSPITAL: (B)(6). NAME OF INDIVIDUAL REPORTING THE INCIDENT: SELF. PHONE NUMBER OF THE REPORTER OR HOSPITAL; UNK. DESCRIPTION OF THE COMPLAINT: CUSTOMER THOUGHT HER BGS WERE HIGH BECAUSE SHE WAS GOING INTO LABOR. WHEN ARRIVED AT HOSPITAL, THEY ADVICE HER SHE WAS DEHYDRATED AND WAS IN DKA. SIGNIFICANT EVENTS LEADING TO THE ER VISIT: NA. PT WAS NOT IN AN ACCIDENT. CAUSE OF ER VISIT AS PER HEALTH CARE PROVIDER: DKA. OUTCOME OF THE ER VISIT. DUE TO DKA, CUSTOMER LOST HER BABY AND WAS HOSPITALIZED FOR TWO DAYS. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF ER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372996 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-386 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death