BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3914391 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-86429
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH PROTRUDED AND LOOSE DRIVE SUPPORT DISK. INSULIN PUMP ALARMED PRIME DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    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

    PHYSICIAN STATED THAT THE INSULIN PUMP ALARMED DURING THE PRIME PROCESS. CUSTOMER IS HOSPITALIZED FOR NON-DIABETES RELATED DIAGNOSIS. THE DRIVE SUPPORT CAP IS PROTRUDED. THE CURRENT BLOOD GLUCOSE READING IS 164 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390000 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR