BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1811044 · Received August 10, 2010

    Report

    Report Number
    3004209178-2010-82408
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR WINDOW AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. THE INSULIN PUMP ALARMED DURING THE PRIME TEST AND BASIC OCCLUSION TEST DUE TO MOISTURE DAMAGE TO THE FORCE SENSOR RESISTOR. THE INSULIN PUMP PASSED THE DISPLACEMENTS TEST. NO DISPLACEMENT ANOMALY WAS NOTED AND THE MOTOR TESTED OKAY.

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED TWICE MOTOR ERROR. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 21.1 MG/DL. THE CUSTOMER STATED THAT SHE WAS NOT BOLUSING WHEN THE ALARM OCCURRED. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND FAILED. ADVISED CUSTOMER TO DISCONTINUE USING THE DEVICE AND REVERT TO BACK PLAN OF MANUAL INJECTIONS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522CAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR