BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4232017 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48453
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO DAMAGE ON THE KEYPAD ASSEMBLY. ALL BUTTONS FUNCTIONED PROPERLY. NO UNLOCKED LCD KEYPAD CONNECTOR DURING VISUAL INSPECTION. INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUTTONS ON THE CUSTOMER'S INSULIN PUMP WERE STICKING. HER BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF REPORTING. SHE STATED THAT SHE HAD PREVIOUSLY HAD A SEVERE SEIZURE-THOUGH SHE DID NOT SPECIFY IF IT WAS RELATED TO HER DIABETES-AND WAS CONCERNED WITH CONTINUING WITH HER PUMP THERAPY. THE INSULIN PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715228 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR