BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4170859 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37862
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 8, 2013
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOLUS WIZARD FUNCTIONED PROPERLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP WAS MISBEHAVING. THE BLOOD GLUCOSE READING WAS 27.0 MMOL/L, WHICH WAS TREATED WITH A MANUAL INJECTION. THE CALLER STATED THAT THE BLOOD GLUCOSE LEVELS HAD BEEN FLUCTUATING EVER SINCE THE START OF INSULIN PUMP THERAPY. IT WAS NOTED THAT THE CUSTOMER DID NOT TRUST THE INSULIN PUMP ANY LONGER DUE TO THE BOLUS WIZARD MISCALCULATING WITHOUT TAKING ACTIVE INSULIN AND OTHER FACTORS INTO ACCOUNT. THE CUSTOMER DISCONTINUED USE OF THE INSULIN PUMP. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648939 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1