BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARASIGM REAL TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143022 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30131
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED ON (B)(6) 2014 FOR HIGH BLOOD GLUCOSE. HIS BLOOD GLUCOSE WAS 440 MG/DL WHEN ADMITTED. HE WAS EXPERIENCING NAUSEA. HE WAS TREATED WITH DIFFERENT TYPES OF INSULIN. TODAY, HE CALLED BECAUSE HIS BLOOD GLUCOSE WAS RISING AGAIN. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 328 MG/DL. HE TREATED WITH MANUAL INJECTIONS AN HOUR AGO. IN TROUBLESHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED DURING THE MANUAL PRIME. THERE WAS NO LEAK. THE SETTINGS AND HISTORY ARE CORRECT. CUSTOMER WAS ADVISED TO CALL BACK WHEN SHE HAS TUBING CLAMPS TO DO THE HIGH PRESSURE TEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603516 PARASIGM REAL TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization