BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103101 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26412
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    May 3, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED LOW BATTERY ALARM OR EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS. IT WAS RECEIVED WITH A MINOR SCRATCHED DISPLAY WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD RECEIVED NO DELIVERY ALARMS AND THAT THE BATTERIES ONLY LASTED ABOUT TWO DAYS. THE BLOOD GLUCOSE READING WAS 135 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581845 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR