BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 1667312 · Received April 23, 2010

    Report

    Report Number
    3004209178-2010-81057
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE FUNCTIONAL TEST INCLUDING THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. THE DEVICE WAS RECEIVED WITH EMPTY RESERVOIR AND 43 INCH INFUSION SET IN THE RESERVOIR TUBE. THE INSULIN PUMP WAS ALSO RECEIVED WITH NO BATTERY TUBE, TEST BATTERY MEASURED (1.6 VOLTS), SCRATCHED SCREEN, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR WINDOW, CRACKED BATTERY TUBE THREADS, SLIGHTLY STRIPPED BATTERY CAP COIN SLOT, LIGHT CORROSION ON THE BATTERY CAP CONTACT AND LIGHT CORROSION IN THE BATTERY TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. THE REPORTER STATED THAT THE CUSTOMER LOST CONSCIOUSNESS AND DROWNED DUE TO HYPOGLYCEMIA. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE REPORTER STATED THAT THE INSULIN PUMP WAS NOT WORKING. THE REPORTER ALSO STATED THAT THE INFUSION SET WAS CUT OFF AT THE HOSPITAL. THE REPORTER STATED THAT HE WILL BE KEEPING THE INSULIN PUMP WHILE THE DOCTOR CONTINUES TO INVESTIGATE THE CUSTOMER'S DEATH. NOTHING FURTHER WAS REPORTED.

    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 CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death