BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2962653 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-91050
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RETURNED WITH BLANK DISPLAY DUE TO BROKEN SOLDER JOINT CONNECTOR AND DAMAGED TRACE PAD ON INTERFACE BOARD. UNABLE TO PERFORM REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST DUE TO BLANK DISPLAY ANOMALY. HOWEVER, UNITS HISTORY WAS DOWNLOADED WITH A TEST INTERFACE BOARD.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN A MEDICAL CENTER DUE TO DIABETES KETOACIDOSIS, CHEST PAIN, AND HIGH BLOOD GLUCOSE OVER 900MG/DL. THE CALLER STATED THAT HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. THE CUSTOMER MENTIONED THAT SHE WAS ON AND OFF THE INSULIN PUMP, AND WHEN THEY DISCONNECTED THE INSULIN DRIP SHE WAS CONNECTED TO THE DEVICE, BUT HER BLOOD GLUCOSE WENT BACK UP AGAIN. THE CUSTOMER DID NOT FEEL COMFORTABLE AND REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65572 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization