BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET PARADIGM

    MDR report key: 8476909 · Received April 3, 2019

    Report

    Report Number
    3003442380-2019-00003
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    October 26, 2016
    Report Date
    April 3, 2019
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006416
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2019. NO RELEVANT TESTING COULD BE PERFORMED. IF LOT INFORMATION WAS AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE WERE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS.   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 THE LOT NUMBER IS PROVIDED TO INVESTIGATE A POTENTIAL ORIGIN OF THE PRODUCT FAILURE IN THE DEVICES MANUFACTURING TRACEABILITY DOCUMENTS.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER 1(B)(6). THE BELOW EVENT HAS BEEN REPORTED TO UNOMEDICAL AS A LEGAL CASE. ON THE (B)(6) 2016 A FEMALE DIABETIC PATIENT HAD HER INSULIN PUMP AND WAS DRIVING TO(B)(6) FROM HER HOME. PATIENTS PUMP MALFUNCTIONED AND UNEXPECTEDLY ADMINISTERED THE ENTIRE RESERVOIR OF INSULIN TO PATIENT WHILE SHE WAS DRIVING ON HIGHWAY (B)(6). PATIENT BLACKED OUT AND CRASHED HER VEHICLE ON THE HIGHWAY. PATIENT SUFFERED SEVERE, DEBILITATING INJURIES, INCLUDING A HYPOGLYCEMIC EVENT, DIABETIC COMA, MULTIPLE FRACTURED VERTEBRAE, AND CRACKED TEETH. NO AVAILABLE CASE DATA INDICATE ANY CAUSAL RELATION BETWEEN CLAIMED EVENT AND ANY INFUSION SET MALFUNCTION. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269828 QUICK SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-397 UNKNOWN 05705244006416

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening