BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3232030 · Received July 5, 2013

    Report

    Report Number
    3004464228-2013-00708
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    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 WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND EMERGENCY ROOM VISIT. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER," IT ADVISES, "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER BLOOD GLUCOSE RESULT WAS 489 MG/DL AT 5:42 AM, AND SHE GAVE HERSELF AN 8U MANUAL INJECTION OF INSULIN, THEN DEACTIVATED THE POD SHE WAS WEARING. SHE ACTIVATED A NEW POD AT 5:49 AM. SHE PROVIDED THE FOLLOWING HISTORY: TIME: 5:58 AM, BLOOD GLUCOSE RESULT (MG/DL): 459; TIME: 6:47 AM, BLOOD GLUCOSE RESULT (MG/DL): 370; TIME: 7:17 AM, BLOOD GLUCOSE RESULT (MG/DL): 388, BOLUS (UNITS): 2.20; TIME: 8:12 AM, BLOOD GLUCOSE RESULT (MG/DL): 301, BOLUS (UNITS): .85. AT 8;27 AM, HER RESULT WAS 294 MG/DL, AND SHE WENT TO THE EMERGENCY ROOM. SHE SAID SHE HAD VOMITED SEVERAL TIMES. SHE ALSO STATED THAT HER BLOOD GLUCOSE RESULT HAD RISEN OVER 500 MG/DL, BUT DID NOT PROVIDE THE TIME FOR THIS RESULT. AT THE HOSPITAL, THE DOCTOR GAVE HER A MANUAL INJECTION OF INSULIN (UNITS UNKNOWN). AT 1:34 PM, SHE WAS RELEASED FROM THE EMERGENCY ROOM WITH A BLOOD GLUCOSE RESULT OF 146 MG/DL. AT 4:07 PM, HER RESULT WAS 125 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307367 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31035

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other