BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8844985 · Received July 31, 2019

    Report

    Report Number
    3004464228-2019-06990
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, EVALUATION CODES WERE UPDATED ON 05 JULY 2018; SPECIFICALLY, (B)(4) WHICH IS NOW INACTIVATED. (B)(4) HAS BEEN USED AS A REPLACEMENT FOR THE INACTIVATED (B)(4) AND REFLECTED AS PART OF THIS Q2 2019 ALTERNATIVE SUMMARY REPORT SUBMISSION. NOT ALL DEVICES WERE RECEIVED FOR EVALUATION. IN THESE CASES, WE WERE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE THROUGH FAILURE ANALYSIS INVESTIGATION. ALL DEVICES RECEIVED UNDERWENT FAILURE ANALYSIS INVESTIGATION. THE RESULTS OF THESE INVESTIGATIONS ARE REPRESENTED, BELOW, ACCORDING TO REPORTED DEVICE, RESULTS, AND CONCLUSIONS CODE COMBINATIONS AND FREQUENCY OF EACH: (B)(4). EXEMPTION NUMBER: 2014031. TOTAL NUMBER OF EVENTS: 1180.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE>1180</NOE> REPORTED EVENTS. FOR EACH EVENT, THE POD¿S NEEDLE MECHANISM FAILED TO DEPLOY AS INTENDED, RESULTING IN A NEEDLE MECHANISM FAILURE. OF THE 1302 TOTAL REPORTED EVENTS, 1180 ARE FROM QUARTER 2 OF 2019. THE REMAINING 122 REPORTS CONTAIN SUPPLEMENTAL AND/OR CORRECTED ALTERNATIVE SUMMARY REPORT (ASR) DATA FROM PRIOR ASR SUBMISSIONS. PLEASE SEE THE FOLLOWING TABLE WHICH PROVIDES FURTHER DETAIL FOR THE REPORTED SYMPTOM OF NEEDLE MECHANISM FAILURE: AGE GROUP: 0-17, FEMALE: 146, MALE: 169, UNKNOWN: 2, GRAND TOTAL: 317. 18-34, 139, 79, 8, 226. 35-51, 132, 106, 4, 242. 52-68, 124, 54, 3, 181. 69-93, 34, 35, 69. UNKNOWN, 48, 24, 73, 145. GRAND TOTAL: 623, 467, 90, 1180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642182 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1