BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1103204 · Received August 8, 2008

    Report

    Report Number
    2032227-2008-01369
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 440 MG/DL. THE CUSTOMER STATED THAT SHE HAD ATTEMPTED SEVERAL SET CHANGES PRIOR TO THE EVENT, BUT HER BLOOD GLUCOSE LEVELS CONTINUED TO RISE. TROUBLESHOOTING WAS PERFORMED, AND THE TIME ON THE INSULIN PUMP WAS CORRECT. IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED SEVERAL AUTO-OFF ALARMS ON THE INSULIN PUMP. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER STATED THAT THERE WAS A CRACK ON THE RESERVOIR WINDOW OF THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization