BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123015 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29530
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    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. 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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE TEST TRANSMITTER AND BLOOD GLUCOSE METER COMMUNICATED PROPERLY TO THE INSULIN PUMP. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE SENSOR GLUCOSE VALUES AND ALL REGISTERED PROPERLY IN THE SENSOR UPDATE HISTORY. THE INSULIN PUMP FUNCTIONED PROPERLY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS SENSOR READINGS ARE INACCURATE. HIS INSULIN PUMP WILL NOT ACCEPT HIS EXACT BLOOD GLUCOSE READINGS. CUSTOMER STATED IF HIS BLOOD GLUCOSE IS 115 MG/DL, HE CAN ONLY ENTER 114 OR 116 MG/DL FOR A CALIBRATION. THIS HAPPENS NINETY PERCENT OF THE TIME. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 179 MG/DL. HE ALSO STATED THERE IS A CRACK NEAR THE RESERVOIR COMPARTMENT. CUSTOMER DOES NOT KNOW HOW THE DAMAGE OCCURRED. HE ALSO STATED THERE ARE LIGHT SCRATCHES ON THE LCD SCREEN. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600733 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR