BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170429 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37800
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A MOTOR ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT SHE WAS PROMPTED TO CALIBRATE WHEN THE INSULIN PUMP WAS IN REWIND MODE. CUSTOMER DOES USE THE SENSOR FEATURE AND THEY WERE ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER ALSO RECEIVED A THRESHOLD SUSPEND ALERT. CUSTOMER STATED THAT THEIR BLOOD GLUCOSE READING WAS AROUND 50 MG/DL TO 68 MG/DL AND THE INSULIN PUMP WAS ALARMING THRESHOLD SUSPEND AT 70 MG/DL. CUSTOMER STATED THAT THEY HAVE A HISTORY OF GOING LOW AT NIGHT AND HAVE ASKED THEIR DOCTOR TO ADJUST THEIR SETTINGS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651857 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR