BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1951844 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-83688
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 11, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET AT NIGHT AND SHE STARTED THROWING UP THE REST OF THE NIGHT. THE CUSTOMER STATED THAT SHE WAS BOLUSING AND NOTHING WAS HAPPENING. THE CUSTOMER STATED THAT THE INFUSION SET WAS REMOVED AT THE HOSPITAL AND FOUND THAT THE CANNULA WAS BENT. THE CUSTOMER STATED THAT SHE DID NOT SMELL INSULIN AND DID NOT SEE LEAKS AT THE SITE. THE CUSTOMER STATED THAT THE RESERVOIR WAS TOTALLY EMPTY. THE CUSTOMER WAS RELEASED AND IT WAS INSERTED A NEW INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED AND IT READ 311MG/DL. THE CUSTOMER TRIED TO BOLUS AND IT DELIVERED. TROUBLESHOOTING WAS PERFORMED. THE TIME ON THE INSULIN PUMP WAS CORRECT. THE DAILY TOTALS MATCHED. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. THE CUSTOMER REPORTED HAVING DIFFICULTIES WITH THE QUICK SERTER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization