BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3030617 · Received March 22, 2013

    Report

    Report Number
    3004464228-2013-00252
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA AND HOSPITALIZATION. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL, BUT DO NOT HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL, FOLLOW THE TREATMENT ADVISE OF YOUR HEALTHCARE PROVIDER" AND "EVEN IF YOU CANNOT CHECK YOUR BLOOD GLUCOSE, DO NOT WAIT TO TREAT SYMPTOMS OF HYPOGLYCEMIA, ESPECIALLY IF YOU ARE ALONE. WAITING TO TREAT SYMPTOMS COULD LEAD TO SEVERE HYPOGLYCEMIA, WHICH CAN QUICKLY LEAD TO SHOCK, COMA, OR DEATH." IT ADVISES, "HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE (NO MATTER HOW MILD). IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BG LEVEL TO CONFIRM."

    Description of Event or Problem · 1

    A HOSPITAL NURSE CALLED TO REPORT THAT THE PATIENT WAS HOSPITALIZED FOR HYPOGLYCEMIA. SHE WAS STARTING TO GO LOW ON (B)(6). THE FOLLOWING BLOOD GLUCOSE RESULTS WERE REPORTED (TIMES WERE NOT PROVIDED): 117 MG/DL, 163 MG/DL, 88 MG/DL, 61 MG/DL, 71 MG/DL, 57 MG/DL, 51 MG/DL, 43 MG/DL, 50 MG/DL, 52 MG/DL, 38 MG/DL, AND 42 MG/DL. THE NURSE DID NOT PROVIDE A HISTORY OF BOLUSES GIVEN, BUT STATED THAT THERE WERE A COUPLE THAT SHE "DOESN'T UNDERSTAND", ESPECIALLY ONE THAT WAS 18.55 UNITS. IN A FOLLOW-UP CALL, THE MOTHER REPORTED THAT ON (B)(6), AT 11:00AM, HER DAUGHTER HAD A LOW BLOOD GLUCOSE RESULT. THEY WERE UNABLE TO BRING HER BLOOD GLUCOSE UP WITH JUICE AND FOOD. THEY REMOVED THE POD AT 2:00PM WHEN THEY COULD NOT GET HER ABOVE 30 MG/DL. THE MOTHER STATED THAT THERE WERE NO BOLUSES IN QUESTION OR MISTAKES IN BOLUSES. THEY HAD CALLED EMS AND SHE WAS GIVEN INTRAVENOUS GLUCOSE. SHE SAID THERE WAS NO CLEAR CAUSE OF THE EVENT. SHE SAID THAT HER DAUGHTER WAS RELEASED FROM THE HOSPITAL ON (B)(6). SHE WAS GIVEN LANTUS INSULIN AND NEEDLES AND PLANNED TO GO BACK ON THE POD WHEN SHE MET WITH HER DOCTOR ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119969 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31037

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization