BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223757 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46618
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH BATTERY CAP DAMAGE DUE TO STRIPPED COIN SLOT (P). PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED WITH CRACKED CASE DISPLAY WINDOW CORNER. UNIT RECEIVED WITH CRACKED BATTERY TUBE THREADS. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP. UNIT RECEIVED WITH CRACKED LCD WINDOW. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP'S BATTERY CAP WAS CRACKED AND COULD NOT BE REMOVED. CUSTOMER REPORTED THAT THE THREADS OF THE BATTERY CAP APPEARED TO BE CRACKED. CUSTOMER DID NOT RECALL ANY SIGINFICANT EVENTS LEADING UP TO THE DAMAGE. CUSTOMER ALSO REPORTED RECEIVING A LOW BATTERY ALERT. BLOOD GLUCOSE LEVEL WAS 137 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705979 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 56 YR