BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1033878 · Received April 24, 2008

    Report

    Report Number
    2032227-2008-00706
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 29, 2008
    Report Date
    April 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 INITIALLY CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS OVER 500 MG/DL BECAUSE THE PISTON IN THE INSULIN PUMP WAS NOT MOVING. THE CUSTOMER THEN STATED THAT SHE WAS HOSPITALIZED TWO WEEKS PRIOR BECAUSE OF HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED FOR THE EVENT. TROUBLESHOOTING HAD BEEN PERFORMED ON THE INSULIN PUMP ON A PREVIOUS PHONE CALL. THE INSULIN PUMP WAS PROGRAMMED CORRECT AND THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER DID NOT HAVE THE TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED BECAUSE OF THE PISTON NOT MOVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAL PRDGM INS CL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization