BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4170846 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37857
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 12, 2014
    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
    TN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, DISPLACEMENT TEST, BASIC OCCLUSION TEST, EXCESSIVE NO DELIVERY ALARM TEST, PRIME TEST AND OCCLUSION TEST. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED CASE AT THE RESERVOIR TUBE CORNERS, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND HAD ISSUES WITH THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 525 MG/DL, WHICH WAS TREATED WITH A MANUAL INJECTION DUE TO NOT TRUSTING THE INSULIN PUMP FOR THE CORRECTION. NO FURTHER DETAILS WERE PROVIDED. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649699 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 69 YR