BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143540 · Received October 6, 2014

    Report

    Report Number
    3004209178-2014-95547
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A STRIPPED BATTERY CAP COIN SLOT, CRACKED BATTERY TUBE THREADS, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND A MISSING END CAP STICKER. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. NO MOTOR ERROR ALARM WAS NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED.

    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

    IT IS REPORTED THAT A CUSTOMER RECEIVED A MOTOR ERROR ALARM ON THEIR INSULIN PUMP WHILE SHE WAS TRYING TO BOLUS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD LED TO THE MOTOR ERROR ALARM. THE CUSTOMER DID NOT MENTION IF HE CONTACTED HIS HEALTH CARE PROVIDER FOR THE HIGH BLOOD GLUCOSE. THE PATIENT ALSO MENTIONED THAT HE WAS UNABLE TO OPEN THE BATTERY CAP TO THE INSULIN PUMP. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A NEW PUMP WAS SHIPPED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622430 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR