BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2151621 · Received June 29, 2011

    Report

    Report Number
    3004464228-2011-00320
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 3, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS THOROUGHLY EVALUATED AND NO EVIDENCE OF ANY MALFUNCTION OR MANUFACTURING DEFICIENCY WAS FOUND THAT WOULD HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. AN AIR BUBBLE, HOWEVER, WAS FOUND WITHIN THE POD'S INSULIN RESERVOIR. THIS TYPICALLY OCCURS WHEN AIR IS INTRODUCED INTO THE POD DURING THE FILL PROCESS AND IS NOT RELATED TO ANY MANUFACTURING PROCESS ISSUE OR PRODUCT DEFECT. "USER ERROR", THEREFORE, IS CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE CUSTOMER'S REPORTED HIGH BG LEVELS. INSULET HAS INITIATED AN INTERNAL INVESTIGATION TO DETERMINE IF MARKETING CAN IMPROVE EDUCATION AND TRAINING RELATED TO THIS TOPIC. THE INVESTIGATION IS IN-PROCESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER "BG'S HAVE BEEN HIGH" WHILE WEARING THIS POD. SHE HAD GIVEN HERSELF A BOLUS IN RESPONSE TO A HIGH BG LEVEL OF 330 MG/DL; THIRTY MINUTES LATER HER LEVELS HAD LOWERED TO 220 MG/DL. HOWEVER, TWO HOURS LATER SHE HAD CHECKED HER BG LEVELS ONCE AGAIN, WHICH ROSE TO 300 MG/DL. NO SPECIFIC DEVICE FAILURE WAS CITED. THE POD WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30461

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other