BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 9138778 · Received October 1, 2019

    Report

    Report Number
    3004464228-2019-09464
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 19, 2019
    Report Date
    September 19, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K180045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY DEPLOYED. INSPECTION OF THE FLUID PATH FOUND THE EXPOSED PORTION OF THE SOFT CANNULA BENT. ALTHOUGH THIS DAMAGE WAS OBSERVED, IT CANNOT BE DETERMINED WHEN OR HOW THIS DAMAGE OCCURRED. NO OTHER DEFECTS OR DEFICIENCIES WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN CORRECTION TO : EXPIRATION DATE CHANGED FROM 1021672 TO 1081672. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO ((B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: 18320. 18296-ENG-AW REV B 06/18. BLOOD GLUCOSE READINGS. CHAPTER 4 / PAGE 56. WARNINGS: BLOOD GLUCOSE READINGS BELOW 70 MG/DL MAY INDICATE HYPOGLYCEMIA (LOW BLOOD GLUCOSE). BLOOD GLUCOSE READINGS ABOVE 250 MG/DL MAY INDICATE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). FOLLOW YOUR HEALTHCARE PROVIDER'S SUGGESTIONS FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S BG (BLOOD GLUCOSE) REACHED 531 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT'S CANNULA WAS FOUND BENT WHEN REMOVED FROM THE INFUSION SITE (ARM). FOR TREATMENT, GAVE CORRECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933951 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C11161851 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR