BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3946031 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-88050
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 21, 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

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 WAS REPORTED BY THE CUSTOMER THAT THEY DO NOT BELIEVE THEIR INSULIN PUMP IS FUNCTIONING PROPERLY. CUSTOMER STATES SHE HER BLOOD GLUCOSE LEVELS HAD BEEN LOW AND HAS CONTACTED HER PHYSICIAN FOR NEW SETTINGS. SHE ALSO STATED THAT THE INSULIN PUMP HAS A CRACK NEAR THE BATTERY COMPARTMENT. CUSTOMER WAS ADVISED TO DISCONNECT FROM DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE NO AIR BUBBLES. AFTERWARDS, THE RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. INSULIN PUMP DID NOT ALARM AND CUSTOMER WAS ADVISED THE DEVICE WAS FUNCTIONING PROPERLY BUT WOULD NEED TO BE REPLACED DUE TO DAMAGE. BLOOD GLUCOSE LEVEL WAS 207 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426023 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR