BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3961415 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-88221
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Removal / Correction Number
    Z-1581-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT WAS MONITORED FOR 2 DAYS AND NO UNEXPECTED BOLUS DELIVERIES WERE NOTED. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS AND A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING HER INSULIN PUMP DELIVERED ON ITS OWN WHILE SHE WAS SLEEPING. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 400 MG/DL. IT IS HIGH BECAUSE SHE HAS BEEN TAKING GLUCOSE TABS TO COMPENSATE FOR THE OVER DELIVERY. SHE HAS CORRECTED FOR THE HIGH USING THE INSULIN PUMP. CUSTOMER WAS SLEEPING WHEN THE DEVICE DELIVERED AN 8.0 UNIT BOLUS. HER BLOOD GLUCOSE DROPPED TO 29 MG/DL AS A RESULT. SHE WOKE FROM HER SLEEP DISORIENTED AND SWEATING. THE DEVICE'S BOLUS HISTORY RECORDED AN 8.0 UNIT BOLUS DELIVERY. CUSTOMER DID NOT PROGRAM THE BOLUS. SHE FEARS THAT A HACKER MAY HAVE TAMPERED WITH HER DEVICE. SHE REQUESTED A LETTER OF ANALYSIS ON THE DEVICE. SHE DECLINED TROUBLE SHOOTING BECAUSE SHE DID NOT HAVE ANY TIME. CUSTOMER IS A NURSE. CUSTOMER WAS ADVISED THAT MEDTRONIC CONSTANTLY MONITORS AND RESPONDS APPROPRIATELY TO CYBER ATTACKS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438225 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention