BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1133346 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-00651
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 AS NO PROD 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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING A BOLUS. THE BLOOD GLUCOSE READING WAS 195 MG/DL AT TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST ON THE PUMP ALARMED AT 0.7 UNITS. HAD CUSTOMER DISCONNECT AND RECONNECT THE INFUSION SET AND RESERVOIR. REQUESTED CUSTOMER TO REWIND THE INSULIN PUMP AND NO INSULIN EXITED DURING THE MANUAL PRIME. PARAMEDICS WERE CALLED AND HER BLOOD GLUCOSE WAS 162 MG/DL AT TIME OF THEIR ARRIVAL. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention