BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10488114 · Received September 3, 2020

    Report

    Report Number
    3004464228-2020-14020
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 23, 2020
    Report Date
    August 24, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    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 FULLY DEPLOYED. THE CANNULA MEASURED THE CORRECT FULL LENGTH ACCORDING TO SPECIFICATION AND DID NOT APPEAR DAMAGED. INSPECTION OF THE CANNULA ASSEMBLY FOUND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. A ROOT CAUSE FOR THE REPORTED, DISLODGED CANNULA COULD NOT BE DETERMINED. AN 0X18 ALARM WAS GENERATED, INDICATING THE DEVICE HAD REACHED AN EMPTY RESERVOIR. THE RESERVOIR WAS CONFIRMED, TO BE EMPTY UPON INSPECTION. THE PRODUCT WAS RETURNED WITH A DIFFERENT LOT NUMBER THAN WAS REPORTED. AND NOTED ON THE INITIAL MDR. CORRECTION TO D(4): LOT NUMBER CHANGED FROM UNAVAILABLE TO L45675, CATALOG NO CHANGED FROM ZXY425 TO ZXP425, EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 9/30/2021. MODEL NO CHANGED FROM 14810 TO 19191, CORRECTION TO G(5): PMA/510(K)#: CHANGED FROM K122953 TO K192659, UNIQUE IDENTIFIER (UDI)#: CHANGED TO (B)(4). CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 3/31/2020.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 326 MG/DL. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. IT WAS NOTED THAT THE CANNULA DISLODGED FROM THE SITE. AS TREATMENT FOR THE HYPERGLYCEMIA, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954315 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45675

    Patients

    Seq Age Sex Outcome Treatment
    1 120 YR