BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530 G INSULIN PUMP

    MDR report key: 4143332 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30006
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE HAD AN EMERGENCY ROOM VISIT ON (B)(6) 2014 DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF EMERGENCY ROOM VISIT 392 MG/DL. AFTER TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE IT WAS FOUND THAT CANNULA WAS BENT. INFUSION SET WILL BE REPLACED. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603295 530 G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization