BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2211221 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00345
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    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 MFG 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 MFG PROCESS ISSUE OR PRODUCT DEFECT. THE OMNIPOD USER'S GUIDE INSTRUCTS USERS ON PROPER FILLING TECHNIQUE AND INCLUDES THE FOLLOWING WARNING: "NEVER, INJECT AIR INTO THE FILL PORT. DOING SO MAY RESULT IN UNINTENDED OR INTERRUPTED INSULIN DELIVERY." INTERRUPTED INSULIN DELIVERY HAS THE POTENTIAL TO RESULT IN HIGH BLOOD GLUCOSE LEVELS. "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 REPORTED THAT SHE EXPERIENCED HIGH BG READINGS (GREATER THAN 250 MG/DL) WITHIN THE FIRST DAY OF WEARING THE POD. SHE WAS UNABLE TO RETRIEVE THE DEVICE'S ALL-HISTORY INFO; IT IS UNK WHETHER CORRECTION BOLUSES HAD BEEN ATTEMPTED. THE CANNULA WAS OBSERVED TO BE KINKED, THOUGH NO OCCLUSION ALARM HAD BEEN INITIATED. THE POD WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30473

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other