BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1092403 · Received August 1, 2008

    Report

    Report Number
    3004209178-2008-00578
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 437 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. IT WAS FOUND THAT THE CUSTOMER HAD CHANGED HER INFUSION SET NUMEROUS TIMES AS A RESULT OF NO DELIVERY ALARMS. THE INSULIN PUMP ALARMED NO DELIVERY DURING THE PRIME TEST. THE PRIME TEST WAS ATTEMPTED AGAIN WITH A NEW INFUSION SET AND RESERVOIR, AND AGAIN THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN UNTIL A REPLACEMENT INSULIN PUMP COULD BE DELIVERED TO HER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization