BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4202247 · Received October 15, 2014

    Report

    Report Number
    3004464228-2014-01555
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2014 AT 9:00 AM, HIS BLOOD GLUCOSE WAS READING 14.0 MMOL/L (252 MG/DL) SO HE GAVE HIMSELF A BOLUS OF INSULIN (EXACT DOSAGE WAS NOT PROVIDED). AT 11:00 AM, HIS BG ROSE TO 24.0 MMOL/L (432 MG/DL) AT WHICH HE GAVE A BOLUS OF 7.0 UNITS OF INSULIN. BY 1:00 PM, HIS BG MEASURED 20 MMOL/L (360 MG/DL) SO HE TOOK ANOTHER 8.0 UNITS OF INSULIN. HE WAS BEGINNING TO FEEL SICK AND AT 6:00 PM HE WAS VERY ILL, WAS VOMITING AND THERE WAS PAIN IN HIS BODY. HE THOUGHT HE WAS HAVING A STOMACH FLU AND DECIDED TO GO TO BED. DURING THE NIGHT, HE TESTED HIS BG LEVELS AND IN ALL FOUR OCCASIONS, IT WAS READING "HIGH" (27.8 MMOL/L) (GREATER THAN 500 MG/DL). THE NEXT MORNING (09/12) HE WAS IN A VERY POOR CONDITION SO HE WAS RUSHED TO THE HOSPITAL IN AN AMBULANCE AND UPON ARRIVAL HIS BG MEASURED 35.0 MMOL/L (630 MG/DL) WITH HIGH KETONES. HE STAYED IN THE HOSPITAL OVERNIGHT AND ON (B)(6) AT 1:00 PM, HE WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654030 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40973

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization