BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141660 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33234
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 INSULIN PUMP TOOK A LONG TIME TO REWIND AND SOUNDED STRANGE. CUSTOMER ALSO STATED THAT WHEN SHE HEARS AN ALARM, SHE GOES BACK INTO THE ALARM HISTORY TO SEE WHAT IT WAS AND IT DOESN'T SHOW. THE ALARM HISTORY WAS CHECKED AND ONLY LOW BATTERY, LOW RESERVOIR AND NO DELIVERY WERE FOUND; NO ERROR ALARMS. CUSTOMER STATED SHE SIS NOT TRUST THE INSULIN PUMP AND WOULD LIKE IT REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621079 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB A5522NABJ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR