BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103448 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26294
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITHIN NORMAL OPERATING CURRENTS. NO UNEXPECTED LOW BATTERY ALARM OR OFF NO POWER ALARM NOTED. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAS BEEN USING BATTERIES LIKE CRAZY. CUSTOMER NOTICED THAT THE INSULIN PUMP HAD A SUDDEN OFF NO POWER ALERT WITHOUT RECEIVING A LOW BATTERY ALERT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 155 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584071 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR