BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951281 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88086
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED OFF NO POWER ALARMS OR LOW BATTERY ALARMS NOTED. UNIT PASSED DISPLACEMENT TEST, SELF TEST, AND A21 ERROR TEST. UNABLE TO PRIME DURING PRIME TEST AND MOTOR ERROR ALARM NOTED DURING BASIC OCCLUSION TEST DUE TO CRACKED END CAP. FURTHER TESTING COULD NOT BE PERFORMED DUE TO PRIME ANOMALY. MOTOR PASSED MOTOR TEST. UNIT RECEIVED WITH STRIPPED BATTERY CAP COIN SLOT, CRACKED BATTERY TUBE THREADS, SCRATCHED SCREEN, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. 2 DAYS PRIOR TO THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 19 MG/DL. THE PARAMEDICS TREATED WITH IV. THE PERCEIVED CAUSE OF LOW BLOOD GLUCOSE WAS OVER BOLUSING WITH 15 UNITS OF MANUAL INJECTION. THE INSULIN PUMP RAN OUT OF INSULIN AND THE CUSTOMER DIDN'T KNOW, SO THEY TREATED WITH MANUAL INJECTION WITHOUT CHECKING THEIR ACTUAL BLOOD GLUCOSE. THE CUSTOMER STATED THAT THEY HAD HIGH BLOOD GLUCOSE BECAUSE THEIR INSULIN PUMP RAN OUT OF INSULIN BUT THE DEVICE DID NOT ALARM. BY THE TIME THE CUSTOMER GOT TO THE EMERGENCY ROOM THEIR BLOOD GLUCOSE WAS 143 MG/DL. THEY WERE CALLING BECAUSE THEY COULDN'T REMOVE THE BATTERY CAP FROM THE INSULIN PUMP AND THE DEVICE WAS ALARMING LOW BATTERY. THE BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 144 MG/DL. THE HISTORY OF THE DEVICE SHOWED LOW BATTERY, LOW RESERVOIR AND NO DELIVERY. NOTHING FURTHER WAS REPORTED. THE DRIVE SUPPORT CAP WAS RECESSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428522 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization