BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4862340 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19859
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    December 4, 2014
    Report Date
    December 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING PRIME/A33 TEST AND MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. MOTOR PASSED MOTOR TEST. UNABLE TO PERFORM OCCLUSION TEST, EXCESSIVE NO DELIVERY TEST, AND PRIME/DELIVERY TEST DUE TO MOTOR ERROR ALARM. UNIT RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED WITH BROKEN BATTERY TUBE THREADS. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS CRACKED BETWEEN THE BATTERY COMPARTMENT AND THE RESERVOIR. THE CUSTOMER DID NOT RECALL HOW THE DAMAGE OCCURRED. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 300 MG/DL, WHICH THE CUSTOMER TREATED WITH A MANUAL INJECTION. THE CUSTOMER WAS UNABLE TO COMPLETE TROUBLESHOOTING AS HE DID NOT SEE WELL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405708 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR