BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181482 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39586
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 9, 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
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP RANDOMLY STOPPED WORKING AND IT MAY HAVE HAD A NO DELIVERY ALARM. CUSTOMER STOPPED USING THE PUMP FOR ABOUT 2 WEEKS BECAUSE OF THE COST OF SUPPLIES. CUSTOMER STARTED BACK ON THE PUMP 2 DAYS AGO. CUSTOMER WAS USING THE MIO AND USING A QUICK SERTER FROM A PAY IT FORWARD SITE. CUSTOMER STATED THAT SHE HITS VEINS A FEW TIMES AND BLOOD WILL SQUIRT OUT. CUSTOMER HAD A BATTERY OUT LIMIT ALARM BECAUSE BATTERY WAS OUT OF THE PUMP SINCE CUSTOMER WAS NOT USING THE PUMP. CUSTOMER ALSO HAD A LOW RESERVOIR DUE TO THE MOTOR ERROR ALARM. CUSTOMER WAS DELIVERING A BASAL WHEN THE PUMP ALARMED A MOTOR ERROR ALARM. CUSTOMER WAS ADVISED THAT NOT USING THE PUMP, SENSOR, AND INFUSION SETS AS A SYSTEM IS OFF LABEL USE. CUSTOMER WAS ABLE TO CONTINUE USING THE PUMP AFTER REWINDING THE PRIMED PUMP AND INSERTING HER RESERVOIR. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660004 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR