BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232416 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-82718
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER HUSBAND DROVE HER TO THE ER. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 108 MG/DL. THE CUSTOMER STATED THAT SHE HAD EXCESSIVE BLEEDING AND POSSIBLE INFECTION AT THE SITE. THE CUSTOMER STATED THAT THE INFUSION SET HAD BEEN INSERTED FOR (B)(6). THE CALLER STATED THAT THE DR BELIEVES SHE MAY HAVE HIT THE MUSCLE AND/OR HAD A SITE INFECTION. THE CUSTOMER STATED THAT SHE LOST A LARGE AMOUNT OF BLOOD AND SHE WAS DIZZY AND FEELING FAINT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization