BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1931500 · Received December 10, 2010

    Report

    Report Number
    3004209178-2010-83563
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS AT THE CLINIC FOR A REGULAR APPT AND SHE WAS INFORMED THAT THE INSULIN PUMP WAS NOT DELIVERING CORRECTLY AS SHE HAS TIMES WHERE HER BLOOD GLUCOSE WAS HIGH AND SOMETIMES LOW. TROUBLESHOOTING WAS PERFORMED. PERFORMED A HIGH PRESSURE AND SELF TEST THE INSULIN PUMP PASSED THE TESTS. REVIEWED THE DAILY TOTALS FOR THE PAST FIVE DAYS AND SHE STATED THAT NONE OF THE BASALS WERE ACCURATE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1