BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4212479 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43381
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXCESSIVE NO DELIVERY ALARMS. THE CUSTOMER ALSO REPORTED A BENT CANNULA AFTER HE HAD REMOVED HIS INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL. HE STATED HE HAD TREATED HIS BLOOD GLUCOSE WITH 5 UNITS OF INSULIN. CUSTOMER ALSO REPORTED AN ODD NOISE FROM THE INSULIN PUMP WHEN HE WAS REWINDING IT. THE CUSTOMER ALSO STATED HE HAD A HEART ATTACK IN MAY. TROUBLESHOOTING FOR THE INSULIN PUMP FOUND INSULIN WAS ABLE TO EXIT DURING A FIXED PRIME. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680690 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR