BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7222271 · Received January 26, 2018

    Report

    Report Number
    3004209178-2018-46391
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    December 1, 2017
    Report Date
    May 24, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169476677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH OPERATING CURRENTS WITHIN SPEC. DEVICE PASSED SELF TEST, UNEXPECTED RESTART ERROR TEST, REWIND, BASIC OCCLUSION TEST AND DISPLACEMENT TEST. HOWEVER, UNABLE TO PRIME DEVICE DURING PRIME OR COMPROMISED FORCE SENSOR SYSTEM ALARM TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO PERFORM OCCLUSION TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT ACCURACY TEST OR VERIFY OVER DELIVERY ANOMALY DUE TO PRIME ANOMALY. DEVICE RECEIVED WITH CRACKED BATTERY TUBE THREADS, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH AND LOW BLOOD GLUCOSE TEN YEARS AGO. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 96 MG/DL AND 400 MG/DL. AT TIME OF INCIDENT AND THE BLOOD GLUCOSE LEVEL WAS 96 MG/DL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 20 MG/DL AND 140-200 MG/DL. THE CUSTOMER WAS TREATED WITH ORANGE JUICE STOPPING TROUBLESHOOT FOR HIGH BLOOD GLUCOSE AND THE CUSTOMER WAS CURRENTLY ON LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE PUMP WAS NOT WORKING FOR THE PAST FEW MONTHS AND ITS SQUIRTING INSULIN. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66700 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS A0723RNASJ 00643169476677

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other