BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3980957 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89933
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST AND ALARMED DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR AND PRIME ALARM. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AND MISSING END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN ALARM FOR A LOOSE DRIVE SUPPORT CAP ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 250 MG/DL. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP. SHE STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED BUT THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. SHE STATED THAT SHE DID NOT RECALL PRESSING ON THE CAP. SHE STATED THAT SHE WAS TAKING STEROID INJECTIONS FOR HER KNEE AND IT CAUSED HER TO REQUIRE MORE INSULIN THAT NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456828 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 45 YR