BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL

    MDR report key: 6900919 · Received September 28, 2017

    Report

    Report Number
    2032227-2017-53874
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    June 20, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER¿S REPORTED VIA PHONE CALL FOR HIS DAUGHTER FOR LOW BLOOD GLUCOSE. PATIENT¿S BLOOD GLUCOSE WAS 29 MG/DL. PATIENT'S CURRENT BG: 59 MG/DL. CUSTOMER STATES SHE HAS BEEN HAVING HIGH AND LOW BLOOD GLUCOSE EVENT 3 MONTHS (B)(6). CUSTOMER STATES HER BLOOD GLUCOSE HAS BEEN IN A RANGE OF 29 MG/DL AFTER CHANGING INFUSION SET THE FOUR HOURS LATER THE BLOOD GLUCOSE IS NORMAL THEN AT NIGHT THE CUSTOMER BLOOD GLUCOSE WAS 200-387 MG/DL AND 129 MG/DL. CUSTOMER REPORTS THE SYMPTOMS RELATED TO THEIR HIGH BLOOD GLUCOSE WAS NAUSEA. CUSTOMER REPORTS THEY DO NOT FEEL OKAY TO TROUBLESHOOT. CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH A SYRINGE. CUSTOMER REPORTS THEY HAVE CONTACTED THEIR HEALTHCARE PROVIDER REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOT. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680852 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL B5723NALJ 00643169507234

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other