BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2233986 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00491
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    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

    NO PRODUCT WILL BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO SPECIFIC FAILURE MODE OF THE SUBJECT POD (THE POD THAT WAS WORN AT THE TIME OF THE CUSTOMER'S HOSPITALIZATION) WAS NOTED IN THE REPORT. BASED ON THE INFORMATION PROVIDED IN THE REPORT AND IN THE ABSENCE OF A DEVICE EVALUATION, WE CANNOT CONCLUDE THAT A DEVICE FAILURE HAD CONTRIBUTED TO THE CUSTOMER'S HYPERGLYCEMIC EVENT. NOTE: THREE DAYS PRIOR TO BEING HOSPITALIZED, THE CUSTOMER HAD CONTACTED INSULET TO REPORT EIGHT PODS THAT SHE WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE PDM (SEVEN OF THE EIGHT COMMUNICATION ISSUES OCCURRED DURING THE PRIMING PROCESS AT START-UP). THIS IS A HIGHLY UNUSUAL EVENT AND IS POTENTIALLY THE RESULT OF A USER-RELATED PROCESS ISSUE DURING SET-UP AS OPPOSED TO PRODUCT-RELATED FAILURES (THOUGH THIS CANNOT BE CONFIRMED WITHOUT THE PODS BEING INVESTIGATED). THE OMNIPOD USER GUIDE CONTAINS A CHAPTER DEDICATED SPECIFICALLY TO POD / PDM COMMUNICATION (CHAPTER 11: COMMUNICATION FAILURES). THE EIGHT PODS WITH COMMUNICATION ISSUES CAME FROM FOUR DIFFERENT LOTS. LOT QUALIFICATION RECORDS FOR ALL FOUR LOTS WERE REVIEWED: ONE LOT CONTAINED (B)(4) FAILURE FOR A COMMUNICATION ISSUE (THE CAUSE OF THE COMMUNICATION ISSUE COULD NOT BE DETERMINED). ULTIMATELY, ALL LOTS PASSED THE ACCEPTANCE CRITERIA. (B)(4). NOTE: THE LOT NUMBER OF THE POD WORN WHILE THE CUSTOMER WAS IN THE HOSPITAL WAS NOT PROVIDED. THE REVIEW OF LOT QUALIFICATION RECORDS PERTAINS ONLY TO THE PODS THAT WERE REPORTED THREE DAYS PRIOR TO THE CUSTOMER'S HOSPITALIZATION.

    Description of Event or Problem · 1

    THE CUSTOMER HAD GONE TO THE HOSPITAL FOR "HIGH BG ISSUES" (NO SPECIFIC READINGS WERE REPORTED, BUT BG LEVELS ARE ASSUMED TO BE GREATER THAN 250MG/DL). A NURSE FROM THE HOSPITAL HAD CALLED FOR INSTRUCTIONS ON HOW TO PROPERLY REMOVE THE POD BECAUSE THE CUSTOMER WAS GOING TO BE PUT ON AN INSULIN DRIP IN ORDER TO TREAT DKA. THE NURSE WHO MADE THE CALL WAS "JUST HELPING OUT" AND WAS THEREFORE ONLY ABLE TO PROVIDE LIMITED INFORMATION ABOUT THE EVENT. LOOKING AT THE CUSTOMER'S CALL HISTORY TO INSULET, ON THE DAY PRIOR TO HER HOSPITALIZATION, SHE HAD EXPERIENCED HIGH BG ISSUES WITH TWO SEPARATE PODS. SHE WAS ADVISED BY PRODUCT SUPPORT TO CONTACT HER HCP DUE TO HER HIGH LEVELS, WHICH IS THE REASON SHE IS NOW IN THE HOSPITAL. NO SPECIFIC FAILURE MODE OR POD ISSUE IS DIRECTLY ASSOCIATED WITH THIS CALL FROM THE HOSPITAL NURSE, THOUGH THREE DAYS PRIOR TO HER HOSPITALIZATION, THE CUSTOMER HAD CONTACTED INSULET TO REPORT EIGHT POD ISSUES; ALL OF THE POD ISSUES REPORTED ON THIS DAY WERE FOR COMMUNICATION ISSUES BETWEEN THE PODS AND THE PDM. (NOTE: NONE OF THESE EIGHT PODS, OR THE PDM, WERE RETURNED FOR EVALUATION.) IT IS UNKNOWN HOW LONG SHE STAYED IN THE HOSPITAL FOR, OR WHAT HER STATUS WAS AFTER THE INSULIN DRIP WAS ADMINISTERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization