BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1031865 · Received April 16, 2008

    Report

    Report Number
    3004209178-2008-00248
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE WILL BE RETUNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED, THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 500 MG/DL. THE CUSTOMER STATED, THAT SHE GOT A NO DELIVERY ALARM AND SHE CHANGED THE INFUSION SET TO RESOLVE THE ISSUE. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DID NOT HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER DID NOT FEEL COMFORTABLE WITH THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL 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 Hospitalization