BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021992 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-80609
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP WAS DELIVERING INSULIN ON ITS OWN. THE CUSTOMER STATED THAT THE PRIME HISTORY SHOWED SEVERAL PRIMES THAT OCCURRED AFTER SHE FELL ASLEEP. THE CUSTOMER ALSO STATED SHE WOKE UP WITH LOW BLOOD GLUCOSE LEVEL OF 2.1 MMOL/L. THE CUSTOMER THEN STATED THAT SHE DOES NOT WEAR A SENSOR OR USE THE LOCK FEATURE ON THE INSULIN PUMP. THE CUSTOMER FURTHER STATED THAT SHE WEARS THE INSULIN PUMP WHEN SLEEPING AND COULD NOT HAVE PRESSED THE BUTTONS BY ERROR. NOTHING FURTHER REPORTED.

    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-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1