BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1033892 · Received April 24, 2008

    Report

    Report Number
    3004209178-2008-00275
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND A BLOOD GLUCOSE READING OF 1037 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER WAS UNABLE TO PERFORM THE HIGH PRESSURE TEST DURING THE PHONE CALL. THE CUSTOMER MENTIONED THAT SHE HAD A SINUS INFECTION AND THE CATHETER FOR THE DIALYSIS GOT INFECTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO., MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization