BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103393 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25270
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO BUTTON RESPONSE, DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. UNABLE TO CONFIRM PRIME ALARM, DUE TO KEYPAD ANOMALY. INSULIN PUMP HAD A LOOSE AND PROTRUDED DRIVE SUPPORT DISK WAS NOTED. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS SQUIRTING OUT INSULIN DURING THE MANUAL PRIME. SHE ALSO REPORTED THAT SHE HAD RECEIVED AN ALARM FOR A LOOSE DRIVE SUPPORT CAP. SHE STATED THAT THE DRIVE SUPPORT CAP APPEARED TO BE PROTRUDED BUT DID NOT PRESS ON THE CAP WHILE CONNECTED. THE BLOOD GLUCOSE READING WAS 444 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583966 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention