BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 4532434 · Received February 11, 2015

    Report

    Report Number
    3003442380-2015-00003
    Event Type
    Injury
    Date Received
    February 11, 2015
    Date of Event
    January 20, 2015
    Report Date
    February 10, 2015
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT HAS BEEN REVIEWED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND EVALUATES THAT NO FURTHER INVESTIGATION CAN BE PERFORMED BEFORE EITHER USED SAMPLES ARE RECEIVED FOR TESTING OR THAT THE LOT NUMBER IS PROVIDED TO INVESTIGATE A POTENTIAL ORIGIN OF THE PRODUCT FAILURE IN THE DEVICES MFG TRACEABILITY DOCUMENTS. UNOMEDICAL A/S HEREBY CONSIDER THIS CAUSE TO BE CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), CUSTOMER STATES THAT THERE WAS A HOSPITALIZATION FOR THEIR HIGH BGS. TIME AND DATE OF HOSPITALIZATION WAS: (B)(6) 2015 - LATE EVENING. BG AT TIME OF HOSPITALIZATION WAS: 649. NAME OF THE HOSPITAL: (B)(6). NAME OF INDIVIDUAL REPORTING THE INCIDENT: (B)(6). PHONE NUMBER OF THE REPORTER OR HOSPITAL:(B)(6). DESCRIPTION OF THE COMPLAINT: DKA - COMA FOR 3 DAYS. SIGNIFICANT EVENTS LEADING TO THE HOSPITALIZATION CONSTANT BENT CANNULAS WITH HIS QUICK SETS. PT EXPRESSED THE FOLLOWING SYMPTOM OF HIGH BGS: THIRSTY, DRY MOUTH, BLURRY VISION, FINGERS CAN LOOK LIKE TURTLE CLAWS. PT CONTACTED THEIR HEALTH CARE PROVIDER FOR HIGH BGS. THE PT HAS TREATED FOR HIGH BGS. DETAILS OF TREATMENT ARE AS FOLLOWS: BOLUSES AND MANUAL INJECTIONS. OUTCOME OF THE HOSPITALIZATION: IV AND INSULIN DRIP. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100467 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-399 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization