BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-515NAP PRDGM INS V 2.1 PL EN

    MDR report key: 1931737 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-83536
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 27, 2010
    Report Date
    November 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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'S BLOOD GLUCOSE WAS UNPREDICTABLE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 240MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER TREATED HER BLOOD GLUCOSE WITH A 3.0 UNITS BOLUS PRIOR TO CALLING. THE TIME AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PUMP DID NOT ALARM. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE DEVICE AND TO REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAP PRDGM INS V 2.1 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-515NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization