BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4765515 · Received May 12, 2015

    Report

    Report Number
    2032227-2015-15378
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    November 1, 2012
    Report Date
    April 21, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS BLOOD GLUCOSE WAS 30 MG/DL THIS MORNING. CUSTOMER STATED THAT THE REST OF THE DAY IT HAS BEEN AROUND 500 MG/DL, EXCEPT FOR NOW IT WAS 142 MG/DL. CUSTOMER STATED THAT LAST NIGHT HIS BLOOD GLUCOSE WAS AT 96 MG/DL. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE TODAY AND IT WAS THE FIRST TIME HE DID NOT WAKE UP IN THE MORNING. CUSTOMER TREATED WITH GLUCOSE TABLETS. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER STATED THAT HE WAS ON THE TOILET AND HE FELL OFF. THE CUSTOMER'S WIFE FOUND HIM HOURS LATER. CUSTOMER DOES NOT USE THE PUMP TO BOLUS. CUSTOMER STATED THAT HE NEEDS TO GO TO EAT DINNER. CUSTOMER WAS ADVISED TO CALL BACK IF HE HAS ANY QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309289 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR