BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAL PRDGM INSULIN CLEAR EN

    MDR report key: 1810099 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-82498
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED BECAUSE SHE HAD SWOLLEN FEET AND LEGS, HAD NAUSEA, AND HER BLOOD GLUCOSE WAS 800 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS CHECKED AND FOUND SOME DISCREPANCIES THAT IT DID NOT APPEAR TO BE USER ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE BOLUS HISTORY REVEALED DIFFERENT BOLUS IN DIFFERENT DAYS. HOWEVER, THE ALARM HISTORY SHOWED AN AUTO OFF ALARM TWENTY MINUTES AFTER SHE BOLUSED THE DAY OF THE ADMISSION. THE CUSTOMER STATED THAT THE AUTO OFF ALARM WAS SET FOR EIGHT HOURS. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND PASSED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAL PRDGM INSULIN CLEAR EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization