BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARASIGM REAL TIME REVEL INSULIN INFUISON PUMP

    MDR report key: 4143042 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29981
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 29, 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
    IN, 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. THIS MDR RELATED TO THE PUERTO RICO MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BROKEN BELT CLIP. CUSTOMER'S BLOOD GLUCOSE WAS 471 MG/DL. HE STATED HIS BLOOD GLUCOSE WAS HIGH BECAUSE HE NEEDED TO CHANGE HIS INFUSION SITE. HE ALSO STATED HE TREATED HIS BLOOD GLUCOSE WITH THE INSULIN PUMP. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603509 PARASIGM REAL TIME REVEL INSULIN INFUISON PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR