BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1030855 · Received April 10, 2008

    Report

    Report Number
    3004464228-2008-00024
    Event Type
    Injury
    Date Received
    April 10, 2008
    Date of Event
    January 26, 2008
    Report Date
    March 10, 2008
    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 DAMAGE OR MANUFACTURING DEFICIENCY WAS FOUND THAT WOULD HAVE EITHER DIRECTLY CAUSED OR CONTRIBUTED TO EITHER INSUFFICIENT OR NO INSULIN DELIVERY. FLUID EXITED THE TIP OF THE CANNULA WHEN THE DRIVE MECHANISM WAS ACTUATED. NO PROBLEM FOUND IN THE RETURNED DEVICE. IT IS UNKNOWN WHY THE USER EXPERIENCED HIGH BG LEVELS. THE USER IS INSTRUCTED IN THE USER GUIDE TO PERIODICALLY CHECK THE INFUSION SITE AND TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SHE HAD A POD WHICH SHE DID NOT THINK WAS DELIVERING INSULIN CORRECTLY. SHE SAID SHE WAS ADMITTED INTO THE HOSPITAL WITH HIGH BGS. SHE SAID SHE PUT THE POD ON AT 6:48P IN 2008. HER BG AND BOLUS HISTORY AFTERWARDS WERE AS FOLLOWS: 8:47 P - BG 335, 8.2U BOLUS. THE NEXT DAY, 6:08 A - BG HIGH. 19.5 U BOLUS. 8:13 A - BG 454, 5.2U BOLUS. 11:17A - BG 398, 9.35U BOLUS. 12:12P - BG HIGH, 7.25U BOLUS 1P - WENT TO THE HOSPITAL. 2P - BG 500, 9.0U BOLUS. 4P - BG 464, 14.0U BOLUS. 5:39P - BG 475, BG 15.95U BOLUS. 6:50P - BG 403, 11.25U BOLUS. 8:16P - BG HIGH, GAVE 18.85U BOLUS "SHORTLY AFTER THAT," REMOVED POD AND GAVE 30U BY INJECTION SHE SAID THEY CHECKED HER KETONES IN THE HOSPITAL AND THEY WERE "HIGH," BUT SHE DID NOT KNOW HOW HIGH. SHE SAID SHE WAS ALSO EXPERIENCING ACID REFLUX WHILE SHE WAS IN THE HOSPITAL. SHE SAID THE SITE (ON HER ABD) WAS NOT WET OR BLOODY, AND THE CANNULA WAS NOT BENT OR KINKED. NO FURTHER INFORMATION OR PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11519

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization