BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-512NAS PRDGM INSULIN SK EN

    MDR report key: 1931495 · Received December 8, 2010

    Report

    Report Number
    2032227-2010-83380
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION AND EXCESSIVE NO DELIVERY TESTS DUE TO THE PRIME ANOMALY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE AND BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS NOT RECEIVING INSULIN FROM HER INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR