BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150283 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34971
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 4, 2014
    Report Date
    July 26, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT FUNCTIONED PROPERLY. UNIT RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014. CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVELS DROPPED AND HE HAD A SEIZURE. BLOOD GLUCOSE LEVELS AT THE TIME OF HOSPITALIZATION 31MG/DL. TROUBLESHOOTING OCCURED. ADVISED INSULIN PUMP WOULD BE REPLACED. CUSTOMER'S BLOOD GLUCOSE LEVELS AT THE TIME OF THE CALL 109MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628561 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization