BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3821383 · Received April 25, 2014

    Report

    Report Number
    3004464228-2014-00544
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    November 22, 2013
    Report Date
    April 21, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND NO EVIDENCE OF ANY MFG DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO 10+ UNITS OF INSULIN IN SIZE, WAS FOUND IN THE INSULIN RESERVOIR. AS THERE WAS NO EVIDENCE THAT THE USER ATTEMPTED TO REMOVE RESIDUAL INSULIN, THIS WAS MOSTLY LIKELY INTRODUCED DURING THE FILL PROCESS. USE ERROR IS THEREFORE DETERMINED TO BE THE ROOT CAUSE OF THE HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE (BG) LEVEL WAS 179 MG/DL BEFORE LUNCH. AFTER LUNCH, HER BG ROSE TO 251 MG/DL, AND BEFORE DINNER HER BGS WERE 284 MG/DL. THE POD WAS WORN BETWEEN 4 AND 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251842 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40531

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR