BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972382 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05139
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED THE MOTOR TEST. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN INAPPROPRIATE LOW RESERVOIR ALERT AND A MOTOR ERROR ALARM ON THE INSULIN PUMP. IT WAS FOUND THAT IT WAS JUST THE MOTOR ERROR ALARM. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THIS ALARM AND STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. HE STATED THAT HE HAD BEEN UNABLE TO REWIND THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 76 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448653 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR