BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150316 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34952
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA, METABOLIC ACIDOSIS, HYPERTENSION, GLUCOSE CYTOSIS AND HYPONATREMIA. BLOOD GLUCOSE VALUE AT THE TIME OF THE INCIDENT WAS OVER 1000 MG/DL. IT WAS STATED THAT THE DRIVE SUPPORT CAP IS FLUSH. NO AIR BUBBLES FOUND IN THE TUBING. NURSE SET UP TIME AND DATE. CUSTOMER IS UNSURE IF THE BASAL AND BOLUS DOSE ARE SET UP CORRECTLY. THE CANNULA IS BENT AT THE TIP BUT NOT SURE IF IT WAS BENT AT REMOVAL. HIGH PRESSURE TEST NOT PERFORMED AS THE CUSTOMER DID NOT HAVE A TUBING CLAMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628637 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A2751NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization