BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3232266 · Received July 9, 2013

    Report

    Report Number
    3004464228-2013-00734
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION FOR DIABETIC KETOACIDOSIS. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "THE OMNIPOD SYSTEM IS DESIGNED TO USE RAPID-ACTING U-100 INSULIN. THE FOLLOWING U-100 RAPID-ACTING INSULIN ANALOGS HAVE BEEN TESTED AND FOUND TO BE SAFE FOR USE IN THE POD: NOVOLOG, HUMALOG, OR APIDRA. BEFORE USING A DIFFERENT INSULIN WITH THE OMNIPOD SYSTEM, CHECK THE INSULIN DRUG LABEL TO MAKE SURE IT CAN BE USED WITH A PUMP. REFER TO THE INSULIN LABELING AND FOLLOW YOUR HEALTHCARE PROVIDER'S DIRECTIONS FOR HOW OFTEN TO REPLACE THE POD" AND "FAILURE TO USE RAPID-ACTING U-100 INSULIN, OR USING INSULIN THAT IS OLD OR INACTIVE, MAY LEAD TO HYPERGLYCEMIA OR DIABETIC KETOACIDOSIS (DKA)."

    Description of Event or Problem · 1

    AN INSULET CLINICAL SERVICES MGR REPORTED THAT SHE RECEIVED A CALL FROM A REFERRING PHYSICIAN ASKING QUESTIONS ABOUT THE TYPE OF INSULIN USED IN THE POD. HE INFORMED HER THAT HE WAS CALLED IN AS AN EXPERT WITNESS IN A CASE WHERE A PT ALLEGED THAT HIS PRIMARY CARE PHYSICIAN PROVIDED HIM WITH A VIAL OF 75/25 INSULIN TO USE IN THE POD. THE PT PUT THE INSULIN IN THE POD AND EVENTUALLY ENDED UP IN THE HOSPITAL IN DIABETIC KETOACIDOSIS. THE PHYSICIAN STATED THE PT WAS IN (B)(6). BECAUSE IT IS A LEGAL CASE, HE IS SWORN TO CONFIDENTIALITY AND COULD NOT PROVIDE OTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312238 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization