BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 969226 · Received December 21, 2007

    Report

    Report Number
    3004464228-2007-00162
    Event Type
    Other
    Date Received
    December 21, 2007
    Report Date
    December 20, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THIS COMPLAINT WILL BE CONSIDERED COMPLETE AND CLOSED. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK INFUSION SITE OFTEN 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 THAT SHE HAD TWO PODS WHICH WERE REMOVED AFTER "ABOUT 24 HOURS" BECAUSE HER BG ROSE TO "THE 300S" AND DID NOT COME DOWN WHEN SHE BOLUSED TO CORRECT IT. SHE SAID THE SITES (ON HER THIGH) WERE NOT WET, RED, OR BUMPY. SHE NOTED THAT THE CANNULA WAS BENT ON ONE OF THE TWO PODS. SHE HAD NOT KEPT EITHER POD AND COULD NOT PROVIDE A SEQ #, BUT WAS ABLE TO PROVIDE A LOT NUMBER FROM THE BOX. BOTH OF THESE PODS WERE REMOVED WHILE SHE WAS IN THE HOSPITAL (SHE SAID SHE IS 9 MONTHS PREGNANT), AND THE NURSE DISPOSED OF THE PODS. SHE WAS ALBE TO ACTIVATE A NEW POD SUCCESSFULLY IN EACH CASE. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT BEING 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 L11368

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other