BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1092104 · Received July 31, 2008

    Report

    Report Number
    2032227-2008-01322
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    May 29, 2008
    Report Date
    July 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO DEHYDRATION AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS NOT REPORTED. THE CUSTOMER STATED THAT PRIOR TO THE EVENT SHE RECEIVED SEVERAL NO DELIVERY ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE INSULIN PUMP ALARMED NO DELIVERY WHEN DISCONNECTED FROM THE CUSTOMER'S BODY. THE CUSTOMER STATED THAT SHE WAS UNABLE TO MANUALLY PUSH INSULIN FROM THE RESERVOIR INTO THE TUBING. USING A NEW INFUSION SET AND RESERVOIR, THE CUSTOMER WAS ABLE TO PRIME THE INSULIN PUMP WITHOUT ANY ALARMS. THE INSULIN PUMP PASSED THE PRIME TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A H7293633

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization