BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4011419 · Received August 14, 2014

    Report

    Report Number
    2032227-2014-08147
    Date Received
    August 14, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO CRACKS ON THE DISPLAY OR ADHESIVE TRACES ON THE KEYPAD OR DISPLAY WERE NOTED. NO COSMETIC DAMAGE WAS NOTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER HAD A CRACK ON THE SCREEN OF THEIR INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT RECORDED. THE CUSTOMER INSISTED ON HAVING THE INSULIN PUMP REPLACED. THE PUMP WAS SENT BACK TO ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486347 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1