BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAH PRDGM INS CL EN ML

    MDR report key: 1843635 · Received September 20, 2010

    Report

    Report Number
    2032227-2010-82707
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 INFORMATION 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 THAT SHE WAS EXPERIENCING BLOOD GLUCOSE LEVELS AS HIGH AS 480 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE TEST. 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-522LNAH PRDGM INS CL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR