BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3600591 · Received January 16, 2014

    Report

    Report Number
    3004464228-2014-00066
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION . WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S HOSPITALIZATION. AN ALARM IS A SAFETY FEATURE AND IS NOT CONSIDERED A MALFUNCTION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE PATIENT REPORTED DURING THE POD ACTIVATION PROCESS HE RECEIVED A POD ALARM DURING PRIMING. HE ALSO RAN OUT OF INSULIN SO HE WAS FORCED TO GO TO THE ER ROOM TO GET MORE INSULIN. UPON ARRIVAL HIS BLOOD GLUCOSE MEASURED 29 MMOI/L (522MG/DL) AND HE WS ALSO SUFFERING FROM CHEST PAIN. HE WS THEN ADMITTED TO THE ISU FOR 4 DAYS FOR A MILD HEART ATTACK. HE DID NOT PROVIDED ANY FURTHER INFORMATION REGARDING THE HOSPITALIZATION OR HIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41925 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14820 L31114

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization