BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4243742 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50422
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    PATIENT

    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

    CUSTOMER COMPLAINED ABOUT SENSOR READING DISCREPANCIES. CUSTOMER STATED THAT THE SENSORS READ 30 TO 50 POINTS BELOW HER BLOOD GLUCOSE VALUE. CUSTOMER STATED THAT THE INSULIN PUMP GOES INTO THRESHOLD SUSPEND WHEN SHE IS NOT LOW. CUSTOMER STATED SHE HAS SEEN BENT CANNULAS AFTER INSERTION; SHE WILL FEEL PAIN AND KNOW SOMETHING IS WRONG. CUSTOMER HAS RECEIVED WEAK SIGNAL ALERTS. LAST READINGS WAS SHOWING BLOOD GLUCOSE AT 105 MG/DL AND SENSOR GLUCOSE AT 150 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727705 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR