BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3964027 · Received May 22, 2014

    Report

    Report Number
    3004464228-2014-00701
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    February 7, 2014
    Report Date
    May 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 MANUFACTURING DEFECT WAS DETECTED. AN AIR BUBBLE, EQUIVALENT TO +30 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 HIGH BLOOD GLUCOSE. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 HER BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: UNK TIME, BG (MG/DL) 599 (ALTERNATIVE METER). TIME: 5:40 PM, BG (MG/DL) 242, BOLUS (U) 3.0 (MANUAL INJECTION). TIME: 9:17 PM, BG (MG/DL) 61.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306627 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40655

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR