BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1893432 · Received November 5, 2010

    Report

    Report Number
    3004464228-2010-01352
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 11, 2010
    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 NOT RETURNED TO THE MFR FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER STATED THAT A KINK WAS SEEN IN THE CANNULA. THERE WAS, HOWEVER, NO REPORT OF AN OCCLUSION ALARM. THE POD WOULD HAVE INITIATED AN OCCLUSION ALARM IF THE FLOW OF INSULIN WAS RESTRICTED/PREVENTED BY THE KINK AND RESULTED IN BACK PRESSURE. THE OMNIPOD 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 IN ORDER TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS. NOTE: THE CUSTOMER STATED THAT SHE HAD BUMPED HER ARM AGAINST A DOOR WHILE WEARING THE DEVICE, WHICH "PROBABLY" RESULTED IN THE HIGH BG LEVELS THAT WERE EXPERIENCED. IN THIS WAY, "USER ERROR" IS CONSIDERED TO BE A POSSIBLE CONTRIBUTING FACTOR TO THE EVENT, THOUGH THIS CANNOT BE CONFIRMED. A FOLLOW-UP MDR SHALL BE SUBMITTED TO REPORT INVESTIGATION RESULTS IF THE DEVICE IS RECEIVED AFTER THIS DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED "HIGHER THAN EXPECTED BG LEVELS (308-GREATER THAN 500MG/DL) WITHOUT INDICATION OF ALARM"; HER BG'S HAD ESCALATED OVER THE TWO DAYS THE POD WAS WORN DESPITE HAVING ADMINISTERED MULTIPLE BOLUSES. AS A RESULT, SHE WAS TRANSPORTED TO THE ER AND DIAGNOSED WITH DKA; SHE WAS GIVEN A MANUAL INSULIN INJECTION VIA SYRINGE AS WELL AS IV FLUID. SHE WAS DISCHARGED LESS THAN FIVE HOURS LATER. THE CANNULA WAS REPORTEDLY KINKED, THOUGH NO ALARM WAS INITIATED BY THE POD. SHE STATED THAT HER HIGH BG LEVELS "PROBABLY" RESULTED FROM BUMPING HER ARM AGAINST A DOOR IN HER HOME. THE POD WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30381

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention