BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAL PRDGM INS CL EN RC

    MDR report key: 1133287 · Received August 21, 2008

    Report

    Report Number
    2032227-2008-01415
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND A HEART ATTACK. THE REPORTED BLOOD GLUCOSE READING WAS 223 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY NUMEROUS TIMES PRIOR TO THE EVENT. IT WAS REPORTED THAT THE CUSTOMER HAD ATTEMPTED TO CHANGE HER INFUSION SET, BUT THE NO DELIVERY ALARM PERSISTED. DURING THE PRIME TEST, THE INSULIN PUMP ALARMED NO DELIVERY. THE INSULIN PUMP WAS PRIMED WITHOUT A RESERVOIR IN PLACE, AND THE NO DELIVERY ALARM DID NOT OCCUR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAL PRDGM INS CL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization