BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2193375 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01888
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR ASSISTANCE WITH THE FIXED PRIME. FOUND THAT THE INSULIN PUMP WAS SHOOTING OUT THE INSULIN DURING THE MANUAL PRIME. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. DURING THE CALL, THE CUSTOMER'S BLOOD GLUCOSE READING WAS 58 MG/DL. THE CUSTOMER TREATED WITH ORANGE JUICE, BUT HIS NEXT BLOOD GLUCOSE READING WAS 55 MG/DL. THE CUSTOMER WAS CONFUSED, AND APPEARED TO BE IN NEED OF MEDICAL ASSISTANCE. THE CUSTOMER'S MOTHER STATED THAT SHE WOULD BE TAKING HIM TO AN EMERGENCY CLINIC. 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-511LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization MMT-377, LOT 647896.| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET