BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4203839 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29956
    Event Type
    Malfunction
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, A BROKEN BELT CLIP SLOT, AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 254 MG/DL. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603963 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR