BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4130020 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26025
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND AND BASIC OCCLUSION TEST. NO MOTOR ERROR ALARM NOTED. INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. INSULIN PUMP WAS UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME AND FILL ANOMALY. THE MOTOR WAS TESTED OUTSIDE OF THE INSULIN PUMP AND PASSED. INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED RESERVOIR TUBE, SCRATCHED RESERVOIR TUBE WINDOW AND 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CANE BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A MOTOR ERROR ALARM ON INSULIN PUMP. THE BLOOD GLUCOSE READING WAS UNK. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. SHE STATED THAT SHE WAS ABLE TO REWIND THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585216 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR