BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1033858 · Received April 25, 2008

    Report

    Report Number
    3004464228-2008-00037
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 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 DEVICE INVOLVED HAS NOT BEEN RETURNED TO THE MFR FOR EVAL AS OF THE REPORT DATE. A F/U REPORT WILL BE SUBMITTED IF THE PROD IS SUBSEQUENTLY REC'D. UNABLE TO CONFIRM ANY PROD MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PROD USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT HE HAS HAD HIGH BLOOD SUGARS. HE WAS ADMITTED TO THE ER IN 2008 DUE TO HIS HIGH BLOOD SUGARS. LOOKING AT HIS HISTORY, IN MANY INSTANCES, CUSTOMER'S BG WAS HIGH, BUT HE DID NOT INITIATE A CORRECTION BOLUS. HE ASSUMED THAT IF HE DID NOT EAT ANYTHING, HIS BASAL INSULIN WOULD BRING HIS SUGAR DOWN. IN OTHER INSTANCES, HE CORRECTED HIS BG WITH INJECTIONS, NOT THROUGH HIS PDM. CUSTOM ALSO HAD A SECOND METER HE WAS USING TO TEST HIS BG. REVIEW OF THE ENTRIES IN HIS PDM SHOWED THAT HIS BG WAS 64 THREE HOURS AFTER ACTIVATION. IT WENT AS HIGH AS 473 OVER THE NEXT 24 HRS, AND WAS AT 425 WHEN HE WENT TO THE HOSP. AT THE TIME OF THE CALL, THE CUSTOMER NOTED THAT WHILE HE WAS IN THE HOSP, CORRECTIONS WERE MADE THROUGH HIS PDM TO BRING HIS BG DOWN, AND THAT HE WAS STILL WEARING THE SAME POD AND HIS BG NUMBERS HAD BEEN UNDER CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention