BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4240446 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49703
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS GIVING REPEATED ALERTS THAT HER BLOOD GLUCOSE WAS HIGH. WHEN SHE CHECKED HER BLOOD GLUCOSE, IT WAS 118 TO 120 MG/DL. THE CUSTOMER THEN TURNED OFF THE SENSOR AND STATED THAT THE ALERT DID NOT RECUR FOLLOWING THE INCIDENT. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP SCREEN WAS TO DARK AND WAS NOT EASY TO READ. SHE FURTHER STATED THAT DURING A BOLUS, SHE HAD TO ESCAPE OUT TO TURN THE BACK LIGHT ON. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722683 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR