BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982089 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06138
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP CAN NOT GET OUT OF THE REWIND SEQUENCE AND THE INSULIN KEPT SQUIRTING OUT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS 288 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE. CUSTOMER WAS NOT WEARING THE DEVICE DURING PRIMING. PROPER PROCEDURES IN HOW TO PUT ON AN ENTIRE SET WAS EXPLAINED TO THE CUSTOMER. CUSTOMER STATED THE PISTON IS TOUCHING THE STOPPER. RESERVOIR WAS ON THE TIRED NOTCH BEFORE THE SECOND ONE, THE DEVICE HAD U, NO AMOUNT. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE. CUSTOMER IS NOT HOME. THE DEVICE MOTOR DID NOT SLOW DOWN OR HAD NUMBERS RAMPING UP OR DOWN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457347 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR UNOMEDICAL SURE T 29G/6MM NEEDLE/18" MMT-862