BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3150266 · Received May 29, 2013

    Report

    Report Number
    3004464228-2013-00507
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S 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 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 CUSTOMER REPORTED THAT SHE ACTIVATED A POD ON (B)(6) AT 2:38 PM. AT 7:30 PM, HER BLOOD GLUCOSE RESULT WAS 82 MG/DL, AND HER RESULTS THAT DAY WERE IN THE NORMAL RANGE. SHE PROVIDED THE FOLLOWING BLOOD GLUCOSE HISTORY FOR (B)(6): DATE/TIME (B)(6): 8:09 AM, BLOOD GLUCOSE: (NO RESULT), BOLUS: 4.0U; DATE/TIME (B)(6): 10:47 AM, BLOOD GLUCOSE: 154 MG/DL; DATE/TIME (B)(6): 2:21 PM, BLOOD GLUCOSE: (NO RESULT), BOLUS: 1.50U; DATE/TIME (B)(6): 10:00 PM, BLOOD GLUCOSE: 257 MG/DL, BOLUS: 10U. DATE/TIME (B)(6): 12:12 AM, BLOOD GLUCOSE: (NO RESULT), BOLUS: 1.6U; DATE/TIME (B)(6): 1:31 AM, BLOOD GLUCOSE: 382 MG/DL, BOLUS: 4.0U; DATE/TIME (B)(6): 4:53 AM, BLOOD GLUCOSE: 244 MG/DL, BOLUS: 2.85U; DATE/TIME (B)(6): 8:10 AM: BLOOD GLUCOSE: 260 MG/DL, BOLUS: 8.05U; DATE/TIME (B)(6): 2:28 PM, BLOOD GLUCOSE: 229 MG/DL, BOLUS: 3.65U; DATE/TIME (B)(6): 10:00 PM, BLOOD GLUCOSE: 340 MG/DL. THE CUSTOMER DEACTIVATED THE POD AND DISCARDED IT. SHE STATED THAT THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233603 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31021

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR