BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAB PRDGM INS V2.1 BL EN

    MDR report key: 1040199 · Received May 8, 2008

    Report

    Report Number
    3004209178-2008-00313
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 27, 2008
    Report Date
    April 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE READING OF 600 MG/DL. THE CUSTOMER WAS CALLED AT HOME FOR TROUBLESHOOTING. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DID NOT HAVE A TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER STATED THAT SHE GOT A NO DELIVERY ALARM PRIOR TO THE HOSPITALIZATION AND SHE CHANGED THE INFUSION SET TO RESOLVE THE ISSUE. ADVISED THE CUSTOMER TO MONITOR HER BLOOD GLUCOSE LEVELS. ADVISED THE CUSTOMER THAT A TUBING CLAMP WILL BE SENT TO HER AND TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization