BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722RNAP PRDGM INS PL EN RC

    MDR report key: 1874063 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82957
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM DURING A MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER WAS UNABLE TO CONDUCT THE DISPLACEMENT TEST. DURING THE MANUAL PRIME, THE INSULIN PUMP FROZE, AND THE BUTTONS DID NOT RESPOND. LATER, THE INSULIN PUMP RESET ITSELF, THEN FROZE AGAIN. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAP PRDGM INS PL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR