BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142012 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32845
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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) SITE, PER VARIANCE 5. INSULIN PUMP HAD A BLANK DISPLAY DUE TO CORRODED BATTERY TUBE AND BATTERY CAP CONTACT. UNABLE TO TEST FOR BATTERY OUT LIMIT, THE OPERATING CURRENTS, LOW BATTERY ALARM AND OFF NO POWER ALARM DUE TO BLANK DISPLAY. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DIED COMPLETELY AND CLEARED ITSELF WITHOUT ALARMING. THE CALLER STATED THAT TWO WEEKS AGO THERE WERE TWO BARS ON THE BATTERY STATUS AND THE DEVICE ALARMED LOW BATTERY. THE CUSTOMER STATED THAT THE SAME THING HAPPENED AT TIME OF CALL, AND THE DEVICE IS COMPLETELY OFF. THE BLOOD GLUCOSE READING WAS 143 MG/DL. THE CALLER MENTIONED THAT THE INSULIN PUMP ALARMED AFTER CHANGING THE BATTERY AND SHE NOTICED THAT THE UNIT HAS MOLDED CORROSION INSIDE OF THE BATTERY COMPARTMENT. ADVISED THE CUSTOMER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DIED COMPLETELY AND CLEARED ITSELF WITHOUT ALARMING. THE CALLER STATED THAT TWO WEEKS AGO THERE WERE TWO BARS ON THE BATTERY STATUS AND THE DEVICE ALARMED LOW BATTERY. THE CUSTOMER STATED THAT THE SAME THING HAPPENED AT TIME OF CALL, AND THE DEVICE IS COMPLETELY OFF. THE BLOOD GLUCOSE READING WAS 143 MG/DL. THE CALLER MENTIONED THAT THE INSULIN PUMP ALARMED AFTER CHANGING THE BATTERY AND SHE NOTICED THAT THE UNIT HAS MOLDED CORROSION INSIDE OF THE BATTERY COMPARTMENT. ADVISED THE CUSTOMER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621791 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR