BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181498 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39593
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE FOR THE PAST THREE DAYS. THE CUSTOMER REPORTED RECEIVING A NO DELIVERY ALARM. SHE THEN STATED SHE WOULD HAVE HIGH BLOOD GLUCOSE DESPITE BOLUSING FOR HER FOOD. THE CUSTOMER BELIEVED HER BASAL RATES WAS NOT BEING DELIVERED TO HER. SHE ALSO STATED SHE HAD ALREADY TROUBLESHOOTED FOR THE INSULIN PUMP TWO DAYS PRIOR. SHE ALSO REPORTED OBSERVING NO INSULIN BEING DELIVERED TO HER FOR HER BASAL RATES. THE CUSTOMER DECLINED TO TROUBLESHOOT. CUSTOMER'S BLOOD GLUCOSE WAS 280 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660036 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR