BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4211633 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44907
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).UNIT UNABLE TO PRIME DURING THE PRIME/A33 TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP, RESERVOIR TUBE CRACKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD DAMAGE NEAR THE RESERVOIR AND THE RIGHT AMOUNT OF INSULIN WAS NOT COMING OUT. CUSTOMER HAS HAD TO TREAT WITH MANUAL INJECTIONS TO BRING THEIR BLOOD GLUCOSE READINGS DOWN. CUSTOMER MENTIONED THAT A PIECE OF THE INSULIN PUMP WAS MISSING. CUSTOMER'S MOST RECENT BLOOD GLUCOSE READING WAS 384 MG/DL AND HAS TREATED WITH THE INSULIN PUMP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692111 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR