BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141642 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33235
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME ALARM TEST DUE TO MOISTURE DAMAGE NOTED IN FORCE SENSOR. INSULIN PUMP PASSED BASIC OCCLUSION AND DISPLACEMENT TEST. INSULIN PUMP HAD AN INTERMITTENT MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4).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 THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING INSULIN BOLUS DELIVERY. CUSTOMER RECEIVED A SECOND MOTOR ERROR ALARM THE NEXT DAY AFTER BOLUS DELIVERY. CUSTOMER STATED THAT THE DEVICE HAS FALLEN OUT OF HER POCKET A COUPLE OF TIMES. DEVICE WAS EXPOSED TO MAGNETIC FIELDS; CUSTOMER USES A MAGNETIC SENSOR AT WORK TO REMOVE CLOTHING DEVICE. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS ABLE TO REWIND THE INSULIN PUMP. BLOOD GLUCOSE LEVEL IS 538 MG/DL; TREATED WITH BOLUS DOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621062 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 18 YR