BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103578 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26668
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED FOR 24 HOURS WITH MULTIPLE BASAL RATES AND ALL OPERATING CURRENTS WERE NORMAL. NO BLANK DISPLAY ANOMALY WAS NOTED. NO DAMAGE WAS NOTED INSIDE OF THE INSULIN PUMP. THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP. THE TRANSMITTER AND BLOOD GLUCOSE METER COMMUNICATED AND READ ALL INFORMATION PROPERLY WITH THE INSULIN PUMP. NO COMMUNICATION OR SENSOR ANOMALY WAS NOTED DURING TESTING.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE WAS 84 MG/DL. CAUSES OF BLANK DISPLAY WERE EXPLAINED TO THE CUSTOMER. CUSTOMER WAS ADVISED TO DISCONNECT. TROUBLESHOOTING WAS PERFORMED. NO DAMAGE TO THE DEVICE. THE DEVICE WAS NOT DROPPED, BUMPED, OR EXPOSED TO MOISTURE. NO DAMAGE NOTED IN THE BATTERY COMPARTMENT, BATTERY CAP, OR SPRING. CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY, DISPLAY DID NOT RETURN. CUSTOMER WAS ADVISED TO CLEAR BATTERY CONTACT AND COMPARTMENT, DEVICE DID NOT TURN BACK ON. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583937 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR