BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4050246 · Received August 31, 2014

    Report

    Report Number
    2032227-2014-14926
    Event Type
    Malfunction
    Date Received
    August 31, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CONSTANT ERROR FOLLOW BY ANOTHER ERROR ALARM DUE TO ISOLATED ISSUE TO THE MOTHERBOARD. NO BLANK DISPLAY, UNABLE TO VERIFY CURRENTS OR BUTTON/KEYPAD DUE TO THE CONSTANT ERROR ALARM ANOMALY. MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED HER SON'S INSULIN PUMP HAS A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE IS 140 MG/DL. THE DEVICE HAS NO PHYSICAL DAMAGE. IT WAS NOT DROPPED OR EXPOSED TO MOISTURE. THE BATTERY COMPARTMENT AND SPRING IS NOT DAMAGED OR CORRODED. CUSTOMER REMOVED THE BATTERY FOR TEN MINUTES, BUT THE DISPLAY DID NOT RETURN. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531516 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR