BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4202166 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37194
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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 OUT KNOWLEDGE. THIS MDR RELATED TO THE (B)(4)MFG SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER STATED HAS BEEN RECEIVING REPEATED NO DELIVERY ALARMS. TROUBLESHOOTING WAS DONE. CUSTOMER BLOOD GLUCOSE WAS 446 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. THE ISSUE THE WAS RESOLVED BY DISCONNECTING HER RESERVOIR AND TUBING AND BY RECONNECTING. THE INSULIN PUMP WORKED FINE DURING THE TROUBLESHOOTING. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648942 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR