BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 10277096 · Received July 15, 2020

    Report

    Report Number
    3004464228-2020-11266
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    July 4, 2020
    Report Date
    July 10, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K162296
    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. ALTHOUGH NO ISSUES WERE NOTED, IT COULD NOT BE CONCLUSIVELY DETERMINED IF THE CANNULA WAS DISLODGED FROM THE INSERTION SITE. 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 L45759. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 11/9/2021. MODEL NO CHANGED FROM 14810 TO 19191. CATALOG NO CHANGED FROM ZXY425 TO ZXP425 CORRECTION TO G(5): PMA/510(K) # CHANGED FROM K192659 TO K162296. UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). CORRECTION TO H(4): DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO (B)(6) 2020

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF 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 THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 500 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. PRIOR TO POD REMOVAL, THE POD'S CANNULA WAS FOUND TO BE DISLODGED FROM THE INFUSION SITE (ARM). AS TREATMENT, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744297 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45759

    Patients

    Seq Age Sex Outcome Treatment
    1