BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1781302 · Received July 28, 2010

    Report

    Report Number
    3004209178-2010-82184
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 707MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DAILY TOTALS MATCHED THE BASAL AND BOLUS. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND PASSED. IT WAS STATED THAT THE INSULIN PUMP WAS EXPOSED TO AN X-RAY MACHINE. PERFORMED A DISPLACEMENT TEST TWICE AND FAILED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization