BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LNAL PRDGM INS CL EN US LN

    MDR report key: 1062702 · Received June 16, 2008

    Report

    Report Number
    2032227-2008-00994
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 STATED THAT SHE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 1100 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT RECORD THE BOLUSES THAT WERE DELIVERED EARLIER TODAY. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED.

    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