BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1882270 · Received October 20, 2010

    Report

    Report Number
    3004464228-2010-01325
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    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 PDM INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER'S DOCTOR STATED THAT THE PDM MAY HAVE BEEN GIVING ERRONEOUS BG READINGS. NO EVALUATION OF THE BG METER CAN BE PERFORMED AS THE DEVICE WILL NOT BE RETURNING. PER THE OMNIPOD USER GUIDE, THE PATIENT IS INSTRUCTED TO CONFIRM BG READINGS WITH A BACK-UP DEVICE BEFORE TAKING ANY ACTION.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE PODS "ARE NOT LASTING 24 HOURS" - THEY "JUST QUIT WORKING" WITH NO ALARMS. ONE EVENING THE CUSTOMER'S BG LEVELS ROSE TO 400 MG/DL AND SHE CHANGED THE POD IN THE MIDDLE OF THE NIGHT. BY NOON THE NEXT DAY, HER BG LEVELS HAD LOWERED TO 25 MG/DL AND SHE WENT INTO DIABETIC COMA - EMS WAS CALLED. THE DOCTOR BELIEVED THE PDM WAS "GIVING HER INCORRECT BG READINGS". THE PDM WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 13100-2B L12197

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention