BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202391 · Received August 4, 2011

    Report

    Report Number
    2032227-2011-01958
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SHE HAS BEEN EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST SIX HOURS. THE CUSTOMER WAS CALLING FROM THE HOSP, WHERE SHE HAD HIP SURGERY. THE CUSTOMER WAS TAKING VICODIN AND PERCOCET FOR PAIN. THE CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 471 MG/DL TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DIDN'T HAVE A TUBING CLAMP FOR THE HIGH PRESSURE TEST. ADVISED THE CUSTOMER THAT THE TUBING CLAMP WOULD BE SHIPPED TO HER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization MMT-397, LOT 9202088| UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET