BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-523NAB PRDGM INSULIN BLUE

    MDR report key: 1813422 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82585
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO ANY MRI OR HIGH MAGNETIC FIELDS. RAN A DISPLACEMENT TEST AND FAILED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-523NAB PRDGM INSULIN BLUE INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR