BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2832588 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-90766
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTON DUE TO CORRODED KEYPAD TRACE. NO BUTTON ERROR ALARMS OCCURRED. HOWEVER, THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE INSULIN PUMP'S DOWN LOAD TRACE HISTORY WITH CARELINK. UNABLE TO CONFIRM UNEXPECTED DUAL SQUARE BOLUS AND BUTTON TRACE HISTORY DUE TO OVERWRITTEN HISTORY FILE. MONITORED THE INSULIN PUMP AND NO UNEXPECTED DUAL SQUARE BOLUS OCCURRED. THE INSULIN PUMP WAS RETURNED WITH A MISSING END CAP STICKER.

    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 THAT THE PARAMEDICS WERE CALLED DUE TO HER LOW BLOOD GLUCOSE OF 42MG/DL. THE CUSTOMER STATED THAT ONCE THE SETTINGS WERE UPLOADED TO THE CARELINK, HER HEALTH CARE PROVIDER ADVISED HER THAT THERE WAS A 4.9 UNITS DUAL SQUARE BOLUS DELIVERED THE DAY OF THE EVENT. THE CUSTOMER STATED THAT SHE WAS TREATED WITH GLUCAGON SHOTS BY HER HUSBAND, WHICH IT DID NOT WORK POSSIBLE BECAUSE OF THE SQUARE BOLUS, AND SHE WAS DRINKING MILK BY THE TIME THE PARAMEDICS ARRIVED. THE CALLER ALSO MENTIONED HAVING ISSUES WITH THE BUTTON PRESS AND THE INSULIN PUMP ALARMED BUTTON ERROR. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization