BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3173004 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00512
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 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 NOT RETURNED FOR EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY" AND "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED. IF IT IS UNTREATED, SEVERE HYPERGLYCEMIA CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA). DKA CAN CAUSE SYMPTOMS LIKE BREATHING DIFFICULTIES, SHOCK, COMA, OR DEATH. IF INSULIN DELIVERY IS INTERRUPTED FOR ANY REASON, YOU MAY NEED TO REPLACE THE MISSING INSULIN - USUALLY WITH INJECTION OF RAPID-ACTING INSULIN. ASK YOUR HEALTHCARE PROVIDER FOR INSTRUCTIONS ON HANDLING INTERRUPTED INSULIN DELIVERY." IT ALSO WARNS, "TEST RESULTS GREATER THAN 13.9 MMOL/L [250 MG/DL] MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 13.9 MMOL/L [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 13.9 MMOL/L [250 MG/DL], FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER."

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER HAD HYPERGLYCEMIA WHILE WEARING A POD. THE MORNING OF (B)(6) 2013, HER BLOOD GLUCOSE RESULTS RANGED FROM 3 MMOL/L TO 13.1 MMOL/L (54 MG/DL TO 236 MG/DL). THAT AFTERNOON AND EVENING, HER RESULTS RANGED FROM 4.1 MMOL/L TO 8.6 MMOL/L (74 MG/DL TO 155 MG/DL), AND SHE GAVE HERSELF THREE BOLUSES TOTALLING 4.04 UNITS. SHE PROVIDED THE FOLLOWING BLOOD GLUCOSE HISTORY FOR (B)(6): TIME: 6:52 AM, BLOOD GLUCOSE: 17.3 MMOL/L (311 MG/DL), BOLUS: 2.65U. TIME: 7:56 AM, BLOOD GLUCOSE: 14.3 MMOL/L (257 MG/DL), BOLUS: 3U. AT 10:51 AM, WITH A RESULT OF 20.8 MMOL/L (37.4 MG/DL), THE POD WAS DEACTIVATED. THE MOTHER STATED THAT SHE WAS SURE THAT THE CANNULA WAS OUT OF THE SKIN, AND HER DAUGHTER COULD SMELL INSULIN. THE MOTHER STATED THAT THE CANNULA WAS "CURLED UP AND NOT STRAIGHT". HER DAUGHTER WENT TO SEE THE SCHOOL NURSE BECAUSE SHE WAS RUNNING HIGH, AND THE MOTHER HAD TO GO TO SCHOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239851 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14820 L30989

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR