BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103697 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25440
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. 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

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS AND ALARMED FOR A BUTTON ERROR DUE TO CORRODED KEYPAD TRACES. THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS COULD NOT BE PERFORMED DUE TO THE UNRESPONSIVE BUTTONS. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP ALARMED BUTTON ERROR THRICE. THE CUSTOMER STATED THAT SHE COULD NOT HEAR THE ALARMS. THE HIGH BLOOD GLUCOSE READING WAS 500 MG/DL, AND SHE EXPERIENCED KETOACIDOSIS. SHE TREATED WITH A MANUAL INJECTION. ON ANOTHER OCCASION, THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE AND TREATED WITH FOOD. SHE STATED THAT SHE HAD HAD THE INSULIN PUMP FOR A LONG TIME AND WAS UNSURE WHETHER THE BUTTON HAD GOTTEN JAMMED. THE MOST CURRENT BLOOD GLUCOSE READING WAS UNKNOWN. SHE SUSPECTED THAT, BECAUSE SHE HAD BEEN ACTIVE, SHE MAY HAVE HIT THE INSULIN PUMP THE WRONG WAY. CRACKS ON THE INSULIN PUMP WERE ALSO OBSERVED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581664 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR