BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3821404 · Received April 25, 2014

    Report

    Report Number
    3004464228-2014-00545
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    November 20, 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. USER 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

    TIME: 4:53 PM - POD ACTIVATED. TIME: 8:46 PM. BLOOD GLUCOSE (MG/DL): 199. BOLUS (UNITS): 3.90U. TIME: 9:20 PM. BLOOD GLUCOSE (MG/DL): 251. BOLUS: 8.50U. TIME: 10:00 PM. BLOOD GLUCOSE (MG/DL): 275- POD DEACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251858 OMNIPOD INSULIN PUMP PUMP, INFUSION, INFULIN LZG INSULET CORPORATION 14000 L40618

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR