BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141984 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33095
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO UNEXPECTED NUMBERS RAMPING DURING OUR TESTING. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED AND MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS.

    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 INSULIN PUMP HAD RAMPING NUMBERS AND AN UNRESPONSIVE KEYPAD DURING A BOLUS DELIVERY. THE BLOOD GLUCOSE READING WAS 587 MG/DL, WHICH WAS UNTREATED, BUT THE CUSTOMER STATED THAT SHE WOULD TREAT WITH A MANUAL INJECTION. THE CUSTOMER'S HUSBAND ALSO NOTED THAT THE INSULIN PUMP HAD ALARMED MOTOR ERROR A WEEK PRIOR. NO OTHER SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. THE CUSTOMER STATED THAT THE MOTOR ERROR ALARM HAD OCCURRED SEVERAL MONTHS AGO; IT WAS UNCLEAR WHEN THE ALARM TOOK PLACE. SHE REPORTED THAT SHE HAD DROPPED THE INSULIN PUMP A FEW TIMES PRIOR TO THE MOTOR ALARM, BUT IT DID NOT HIT THE FLOOR BECAUSE THE TUBING WOULD STOP IT FROM HITTING THE GROUND. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621652 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR