BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1180064 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-00779
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER SON WAS UNCONSCIOUS WITH LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 112 MG/DL. THE PARAMEDICS WERE CALLED AND CHILD WAS REVIVED. TROUBLESHOOTING WAS PERFORMED. THE DAILY TOTALS AND THE BASAL RATES WERE CORRECT. IT WAS REPORTED THAT THE CUSTOMER DID NOT TAKE ANY BOLUS SINCE LAST NIGHT AT DINNER. THE PRIME HISTORY SHOWED THAT THE CUSTOMER DID NOT PRIME THE INSULIN PUMP UNTIL THE MORNING. THE FIXED AND MANUAL PRIME WAS NORMAL. THE MOTHER STATED THAT CUSTOMER HAD SEVERAL DAYS OF LOW BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization