BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4190502 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41286
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST. NO MOTOR ERROR ALARM NOTED. NO UNEXPECTED MOTOR NOISE NOTED DURING TESTING. INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. THE MOTOR WAS TESTED OUTSIDE OF THE INSULIN PUMP AND PASSED. INSULIN PUMP HAD CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR WINDOW, CRACKED CASE AT WINDOW DISPLAY CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP ALARMED FOR MOTOR ERROR DURING THE MANUAL PRIME PROCESS. BLOOD GLUCOSE READING WAS 127 MG/DL. THE CUSTOMER STATED THAT THE MOTOR WAS MAKING STRANGE NOISES. TROUBLESHOOTING WAS PERFORMED. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ALARM. THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE REWIND SEQUENCE WAS COMPLETED BUT THE CUSTOMER COULD NOT GET OUT OF THE PRIME AND REWIND SEQUENCE. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668953 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR