BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1030864 · Received April 8, 2008

    Report

    Report Number
    3004464228-2008-00021
    Event Type
    Malfunction
    Date Received
    April 8, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    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 RETURNED DEVICE WAS EVALUATED FOR THE REPORTED PROBLEMS. IT WAS DETERMINED THAT THE NEEDLE MECHANISM HAD NOT FIRED DUE TO INTERFERENCE FROM A DAMAGED COMPONENT. THE USER FAILED TO NOTE THIS CONDITION WHICH WOULD BE VISIBLE VIA THE VIEWING PORT UPON PLACEMENT IF THE LABELING IS FOLLOWED. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE DHR PROVIDES EVIDENCE THAT THE LOT MET THE ACCEPTANCE LEVEL PRIOR TO RELEASE.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A POD THAT HE PLACED BEFORE BED. WHEN HE PLACED THE POD HE WAS NOT SURE HE REMEMBERS FEELING THE NEEDLE INSERT. HOWEVER THE SYSTEM CONTINUED THROUGH THE PROCESS SO HE WENT TO BED. THE BG WAS 92 AT THE TIME OF PLACEMENT. WHEN HE WOKE UP HIS BG WAS 266 UPON INSPECTION OF THE POD IT DID NOT LOOK AS IF THE CANNULA WAS INSERTED. WHEN HE REMOVED THE POD HE PLACED IT ON A TABLE AND IT WAS THEN THAT THE CANNULA INSERTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11551

    Patients

    Seq Age Sex Outcome Treatment
    1 Other