BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240457 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49713
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP HAD BROKEN BATTERY TUBE THREADS, A CRACKED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A BROKEN RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, A CRACKED BELT CLIP SLOT, A MISSING END CAP STICKER AND A STAINED ADDRESS AND SERIAL NUMBER LABEL.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY CAP FOR THE CUSTOMER'S INSULIN PUMP WAS STRIPPED AND PARTS OF IT WERE MISSING. THE CUSTOMER STATED SHE COULD NOT GET THE INSULIN PUMP TO TURN ON DUE TO THE DAMAGED BATTERY CAP. HER BLOOD GLUCOSE WAS 263 MG/DL. THE CUSTOMER STATED THE BATTERY CAP WOULD NOT SCREW ON AND WOULD NOT POWER ON AS A RESULT. THE CUSTOMER STATED THAT THREADING ON THE BATTERY CAP WAS MISSING AND THERE WERE CRACKS AND PARTS MISSING IN THE BATTERY COMPARTMENT. THE CUSTOMER STATED SHE WAS KEEPING THE INSULIN PUMP IN HER BRA AND THE DAMAGE COULD BE DUE TO PERSPIRATION. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722221 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR