BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183027 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39987
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP ALARMED FOR NO DELIVERY. BLOOD GLUCOSE READING WAS AROUND 270 MG/DL. CUSTOMER HAD TREATED WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THE ALARMS OCCURRED 5 TO 6 HOURS AFTER INSERTING INFUSION SETS. THE ALARM ALSO OCCURRED AFTER A BOLUS AT TIMES. THE CUSTOMER HAD GONE THROUGH 4 SETS DUE TO THE NO DELIVERY ALARMS IN THE PAST WEEK. CUSTOMER ALSO MENTIONED EXPERIENCING BENT CANNULAS. THE CUSTOMER STATED THAT SHE TRIED DIFFERENT INFUSION SETS AND BELIEVES THE INSULIN PUMP WASN'T AT FAULT SINCE IT HAD BEEN REPLACED. CUSTOMER HAD CALLED SEVERAL TIMES REGARDING THIS ISSUE AND WENT THROUGH THE TROUBLESHOOTING PROCESS. ADVISED TO CALL BACK WHEN THE NO DELIVERY ALARMS ARE OCCURRING SO TROUBLESHOOTING CAN BE PERFORMED. THE CUSTOMER REFUSED TO SEND THE SET AND RESERVOIR BACK FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661903 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR