BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4201174 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43251
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED SEVERAL SENSOR ERRORS AND THAT THE SENSORS HAD INACCURATE GLUCOSE READINGS. THE BLOOD GLUCOSE READING 250 MG/DL. THE CUSTOMER STATED THAT THE SENSOR GLUCOSE VALUE WOULD SOMETIMES BE OFF BY 200 POINTS COMPARED WITH THE BLOOD GLUCOSE VALUE. HE ALSO NOTED A CALIBRATION ERROR AND BAD SENSOR ALERT. THE CUSTOMER STATED THAT HE HAD ALSO HAD AN ISSUE WITH BENT INFUSION SET CANNULAS AND SLOW INSULIN DELIVERY WHEN HE MIGHT HAVE LIED ON THE INFUSION SITE WHILE SLEEPING. HE STATED THAT THE BACK PRESSURE MAY NOT BE ENOUGH TO TRIGGER THE NO DELIVERY ALARM BUT SLOW ENOUGH TO ALLOW HIS BLOOD GLUCOSE TO ELEVATE. HE COMPLAINED OF FEELING LOUSY. HE ADVISED THAT THE CANNULA MAY BEND AGAINST MUSCLE ON LEAN CUSTOMERS. HE STATED HE INSERTED THE INFUSION SET MANUALLY. HE ADVISED THAT HE WOULD CHECK ON HIS SAMPLES UPON ARRIVAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681861 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR