BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1080479 · Received July 21, 2008

    Report

    Report Number
    2032227-2008-01268
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    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 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 STATED THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 445 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. IT WAS FOUND THAT AT TIMES THE RESERVOIR IS USED FOR MORE THAN FOUR DAYS. THE CUSTOMER'S MOTHER WAS ADVISED OF THE PROPER RESERVOIR CHANGE PROCEDURE. THE INSULIN PUMP FAILED TO DELIVER INSULIN DURING THE FIRST PRIME TEST, SO A SECOND PRIME TEST WAS PERFORMED WITH A NEW SET AND RESERVOIR. THE INSULIN PUMP PASSED THE SECOND PRIME TEST. AT THE TIME OF THE INITIAL CALL, THE CUSTOMER'S MOTHER DID NOT HAVE A TUBING CLAMP TO PERFORM A HIGH PRESSURE TEST, SO A TUBING CLAMP WAS SENT TO HER. UPON RECEIVING THE TUBING CLAMP, THE CUSTOMER'S MOTHER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST; HOWEVER, THE CUSTOMER'S MOTHER WAS UNCOMFORTABLE WITH THE INSULIN PUMP, SO A REPLACEMENT INSULIN PUMP WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722CAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722CAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization