BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2202478 · Received August 5, 2011

    Report

    Report Number
    3004464228-2011-00395
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 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 PDM WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO TEST THE FUNCTIONALITY OF THE BG METER TO DETERMINE THE DEVICE WAS CAPABLE OF PROVIDING ACCURATE BG READINGS. BASED SOLELY ON THE INFO PROVIDED IN THE REPORT, WE ARE UNABLE TO CONCLUDE THAT A DEVICE MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO ERRONEOUS BG READINGS, RESULTING IN THE CUSTOMER'S SEIZURE. NO CONCLUSION CAN BE DRAWN. NOTE: A CONTROL SOLUTION TEST HAD BEEN PERFORMED AND RESULTS FELL "WITHIN RANGE," WHICH IS AN INDICATION THE PDM WAS FUNCTIONING PROPERLY (THOUGH THIS CANNOT BE CONFIRMED WITHOUT AN INVESTIGATION). PER USER GUIDE INSTRUCTIONS, A BACK-UP METER WAS USED TO CONFIRM BG READINGS WHEN READINGS FROM THE PDM BECAME SUSPECT. A REVIEW OF LOT QUALIFICATION RECORDS WAS UNABLE TO BE PERFORMED AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED THAT HIS DAUGHTER "HAD A SEIZURE" AND WAS "NOT RESPONSIVE." HE SAID THE PDM "WAS READING 365 MG/DL AND THEN 65 MG/DL"; HE BELIEVED THESE "INCONSISTENT READINGS" HAD CAUSED THE SEIZURE. NOTE: A CONTROL SOLUTION TEST HAD BEEN PERFORMED WITH THE PDM AND READINGS FELL "WITHIN RANGE." THE CUSTOMER WAS "DOING BETTER" THE DAY FOLLOWING THE EVENT. A BACK-UP METER WILL BE USED IN PLACE OF THE PDM. THE PDM WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other