BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1032824 · Received April 21, 2008

    Report

    Report Number
    3004209178-2008-00261
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. THE FATHER STATED THAT THE CUSTOMER WAS CHANGING THE INFUSION SET AND SHE ACCIDENTALLY PERFORMED THE MANUAL PRIME WHILE SHE WAS CONNECTED TO THE INFUSION SET. THE CUSTOMER WAS NOT FEELING WELL ENOUGH TO TROUBLESHOOT DURING THE PHONE CALL. HOWEVER, THE FATHER WAS ATTEMPTING TO CHANGE THE INFUSION SET PRIOR TO THE PHONE CALL AND HE STATED THAT INSULIN WAS SHOOTING OUT OF THE NEEDLE DURING THE PRIME. THE INSULIN PUMP ALSO GAVE AN ALARM DURING THE PRIME. ADVISED THE FATHER THAT THE INSULIN PUMP WOULD BE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization