BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1850043 · Received September 27, 2010

    Report

    Report Number
    2032227-2010-82768
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. 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 HIGH BLOOD GLUCOSE LEVELS FOR THE PAST FEW DAYS. TROUBLESHOOTING WAS PERFORMED, AND THE DAILY TOTALS DID NOT ADD UP CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE TEST. THE CUSTOMER ALSO STATED THAT HER GLUCOSE METER IS NOT GIVING CORRECT BLOOD GLUCOSE READINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR