BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512NAS PRDGM INSULIN SK EN

    MDR report key: 1032821 · Received April 21, 2008

    Report

    Report Number
    2032227-2008-00682
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION 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 FOR HIGH BLOOD GLUCOSE AND SHORTNESS OF BREATH. NO BLOOD GLUCOSE READING WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND 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 ALSO STATED THAT AFTER CONTACTING HER NURSE TO PROGRAM THE INSULIN PUMP, ONE OF THE BUTTONS WOULD NOT RESPOND TO ANY OF THE BUTTON PRESSES. THE CUSTOMER FELT UNCOMFORTABLE WITH THE INSULIN PUMP AND WANTED IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization