BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103709 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25428
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD A BUTTON ERROR ALARM DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED WEAK BATTERY ALARM NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED WEAK BATTERY, THEN BUTTON ERROR AFTERWARD. THE BLOOD GLUCOSE READING WAS 85 MG/DL. THE CUSTOMER STATED THAT SHE RECEIVED THE WEAK BATTERY SIGNAL, AND THE NUMBERS STARTED GOING UP ON THE DISPLAY. ADVISED REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581697 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR