BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2112382 · Received May 26, 2011

    Report

    Report Number
    2032227-2011-01336
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURIN THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME ALARM. THE INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 689 MG/DL. THE CUSTOMER WAS NOT FEELING WELL, AND DECIDED TO GO TO THE DOCTOR. THE CUSTOMER THEN WAS TOLD TO GO TO THE EMERGENCY ROOM. TROUBLESHOOTING WAS ATTEMPTED, BUT THE INSULIN PUMP ALARMED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization