BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4133398 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31393
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. NO BUTTON ERROR ALARM COULD BE VERIFIED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT TURN ON AND HAD A BLANK DISPLAY. CUSTOMER MENTIONED NOTICING CONDENSATION UNDER THE DISPLAY. CUSTOMER STATED THAT THE INSULIN PUMP MAY HAVE BEEN EXPOSED TO SWEAT AND WATER WHILE PLAYING VOLLEYBALL. CUSTOMER STATED THAT THE INSULIN PUMP KEPT TURNING OFF AND ON AND THE BOLUS BUTTON WAS NOT WORKING. CUSTOMER ALSO STATED THAT THERE WERE CRACKS ON THE SCREEN. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 154 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613374 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR