BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4233081 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48646
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTIONED PROPERLY WHEN A BATTERY WAS INSERTED. NO UNEXPECTED RESET ANOMALY WAS NOTED. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND NO BATTERY ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BATTERY OUT LIMIT ALARM EVEN WITH A GOOD BATTERY AND WAS BEING ASKED TO ENTER THE DATE AND TIME. CUSTOMER STATED THAT THIS HAPPENED 3 TIMES IN THE PAST 10 DAYS. CUSTOMER STATED THAT THIS OCCURRED DURING NORMAL USE EVEN WHEN THE BATTERY STILL HAD 3 BARS. CUSTOMER WOULD CHANGE THE BATTERY RIGHT AWAY AND THE ISSUE WOULD STILL OCCUR. CUSTOMER'S MOST RECENT BLOOD GLUCOSE LEVEL WAS 171 MG/DL. CUSTOMER WILL BE SENT A REPLACEMENT BATTERY CAP SINCE A BATTERY OUT LIMIT ALARM MAY INDICATE A LOOSE BATTERY CAP. CUSTOMER WAS ADVISED TO MONITOR THE PUMP. CUSTOMER CALLED BACK AND AFTER USING THE NEW BATTERY CAP, HE STILL RECEIVED AN ALARM. CUSTOMER RAN A SELF TEST AND THE PUMP PASSED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 220 MG/DL. CUSTOMER STATED THAT THE PUMP ALARMED AFTER THE BATTERY CHANGE. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714348 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR