BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8643800 · Received May 27, 2019

    Report

    Report Number
    2032227-2019-07359
    Event Type
    Injury
    Date Received
    May 27, 2019
    Date of Event
    August 1, 2018
    Report Date
    May 27, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169513877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 515 MG/DL. THE CUSTOMER TAKE MANUAL INJECTIONS AND THEN BLOOD GLUCOSE WENT TO THE 385 MG/DL. CUSTOMER WAS EXPERIENCED MULTIPLE BLOOD GLUCOSE LEVEL'S SUCH AS 212, 315, 204 AND 200 MG/DL. CUSTOMER REPORTED THAT SHE WENT OUT TO EAT AND HAD THREE SLICES OF ORANGES AND THEY WERE NOT THE WEDGES, AND FOUR SLICES OF KIWI AND ALSO HAD SPOONFUL OF COTTAGE CHEESE AND FRIED RICE AND A FEW PIECES OF PEANUT BUTTER CHICKEN AND TWO PIECES OF SESAME CHICKEN ALL SHE HAD TO EAT AND THEN HAD UNSWEET TEA. AFTER THAT SHE WAS NOT FEELING WELL. CUSTOMER WAS PASSED OUT AND THEN HER HUSBAND TAKE HER TO THE HOSPITAL. CUSTOMER REPORTED THAT THE DOCTOR CHECK HER BLOOD GLUCOSE AT 2 PM WITH NO FOOD AND THE BLOOD GLUCOSE WAS 265 MG/DL AT THAT TIME. DOCTOR MADE CHANGES TO SETTING ADJUSTMENT IN THE INSULIN PUMP. CUSTOMER DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THAT THE INSULIN PUMP'S SCREEN HAD A SCRATCHES ON IT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437516 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB A5723LNABJ 00643169513877

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization