BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    MDR report key: 1210209 · Received October 22, 2008

    Report

    Report Number
    2032227-2008-01822
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 9, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FMF
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND A SEIZURE. THE REPORTED BLOOD GLUCOSE READING WAS 419 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME TEST PASSED. HOWEVER, DURING THE HIGH PRESSURE TEST, INSULIN WAS FOUND LEAKING FROM THE RESERVOIR. THE CUSTOMER'S FATHER STATED THAT THE RESERVOIR USED BEFORE THE EVENT HAS ALSO LEAKED. THE CUSTOMER'S MOTHER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST WITH A NEW RESERVOIR AND INFUSION SET, AND THE INSULIN PUMP PASSED THE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10PK PRDGM 1.8ML 13L DISPOSABLES FMF MEDTRONIC MINIMED MMT-326A WD3008237

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization