BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4110481 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27374
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE MOTOR WOULD NOT SLOW DOWN OR RECOGNIZE THE RESERVOIR DURING PRIMING. THE BLOOD GLUCOSE READING WAS 355 MG/DL. HE STATED THAT INSULIN SQUIRTED OUT. HE CONFIRMED THAT HE WAS DISCONNECTED FORM THE INSULIN PUMP WHILE PRIMING. HE STATED THAT THE ISSUE OCCURRED WITH SEVERAL DIFFERENT SETS. HE STATED THAT THE TOP OF THE RESERVOIR WAS NOT WET. HE STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. HE WAS ADVISED TO HOLD THE ACT BUTTON UNTIL INSULIN BEGAN TO EXIT THE TUBING AND REPORTED THAT INSULIN DID NOT CONTINUE TO DRIP AFTER RELEASING THE ACT BUTTON. HE STATED THAT THE MOTOR DID NOT SLOW DOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592450 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR