BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2081389 · Received April 29, 2011

    Report

    Report Number
    3004464228-2011-00181
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND FOUND TO BE FUNCTIONING AS EXPECTED. NO MALFUNCTION OR PRODUCT CONDITION THAT COULD HAVE CAUSED THE ERRATIC READINGS REPORTED BY THE CUSTOMER OR CONTRIBUTED TO THE PT'S HYPERGLYCEMIA WERE DETECTED. TESTING PERFORMED ON THE OMNIPOD BLOOD GLUCOSE METER CONFIRMED THAT ALL READINGS WERE WITHIN THE SPECIFIED TOLERANCE LIMIT. THE BLOOD GLUCOSE READINGS REPORTED BY THE CUSTOMER SHOW THAT THE OMNIPOD BLOOD GLUCOSE METER WAS READING HIGHER THAN THE COMPARISON METER WHEN THE TWO VARIED SIGNIFICANTLY. FALSELY HIGH BLOOD GLUCOSE READINGS CAN NOT BE CONSIDERED TO CONTRIBUTE TO HYPERGLYCEMIA. THE OMNIPOD USER GUIDE INSTRUCTS USERS THAT "IF YOU ARE EXPERIENCING SYMPTOMS THAT ARE NOT CONSISTENT WITH YOUR BLOOD GLUCOSE TEST AND YOU HAVE FOLLOWED ALL INSTRUCTIONS DESCRIBED IN THIS USER GUIDE, CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY."

    Description of Event or Problem · 1

    THE PT, WHO IS PREGNANT, REPORTED BEING HOSPITALIZED WITH BLOOD GLUCOSE BETWEEN 400 AND 500 MG/DL (NO SPECIFIC READINGS OR TIME REPORTED). WHILE IN THE HOSPITAL, THE PT DISCOVERED THAT THE OMNIPOD SYSTEM BLOOD GLUCOSE METER'S READING WAS "WIDELY ERRONEOUS" WHEN COMPARED ANOTHER METER. THE OTHER METER READ 68 MG/DL IN 3 SEPARATE READINGS AND WITHIN FIVE MINUTES THREE READINGS ON THE OMNIPOD'S BLOOD GLUCOSE METER WERE 189, 60 AND 98 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B 50010

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization