BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1052819 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-00365
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 FOR DIABETIC KETOACIDOSIS AND SEIZURES. THE CUSTOMER STATED THAT SHE HAS EPILEPSY AND SHE MAY HAVE HAD THE SEIZURES WHILE BOLUSING FOR HER HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT HER DR WANTED THE INSULIN PUMP REPLACED. NO FURTHER TROUBLESHOOTING WAS PERFORMED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. ALSO ADVISED THE CUSTOMER TO TRY A DIFFERENT INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization