BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3791266 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84283
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. CRACKS TO THE RESERVOIR TUBE LIP, RESERVOIR TUBE WINDOW, BATTERY TUBE THREADS A SCRATCHED CASE ALSO NOTED.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP STOPPED PRIMING AND ALARMED. A NEW BATTERY WAS INSERTED, BUT THE ANOMALY CONTINUED. THE BLOOD GLUCOSE READING WAS 216MG/DL. TROUBLESHOOTING WAS PERFORMED, AND INSULIN SQUIRTED OUT AS WELL THE DEVICE WAS STUCK IN THE PRIME LOOP. THE CALLER WAS UNSURE IF THE DRIVE SUPPORT CAP WAS PROTRUDE, LOOSE, OR STICKING OUT. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERTED TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268744 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR