BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1851610 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-82934
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    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 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 HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 268 MG/DL. IT WAS STATED THAT THE CUSTOMER CALLED THE DAY BEFORE AND STATED THAT SHE FELT SICK AND HAVE A HEADACHE. THE CUSTOMER REQUESTED MEDICAL ASSISTANCE. THE SPOUSE CALLED THE PARAMEDICS AND THEY TREATED THE CUSTOMER. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND THE ALARM HISTORY WERE CORRECT. RAND A FIXED PRIME TEST AND THE DEVICE PASSED THE TEST. PERFORM A HIGH PRESSURE TEST TWICE AND THE DEVICE DID NOT ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization