BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241209 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50059
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD CONSTANT FAILED BATTERY TEST AFTER BATTERY INSERTION DUE TO FAULTY BATTERY TUBE. UNABLE TO TEST THE OPERATING CURRENTS, LOW BATTERY ALARM, OFF NO POWER ALARM AND SENSOR CALIBRATION ERROR ALARM DUE TO FAILED BATTERY TEST ALARM. UNIT HAD MINOR SCRATCHED DISPLAY WINDOW AND 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS DONE. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. CUSTOMER MENTIONED ALSO ABOUT HIS SENSORS NOT STICKING AND GOT CALIBRATION ERRORS. CUSTOMER DECLINED TO TROUBLESHOOT. CUSTOMER STATED SHE BOUGHT NEW BATTERIES AND THE INSULIN PUMP WORKED AGAIN ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND WAIT FOR THE REPLACEMENT TO AVOID ADDITIONAL ISSUES WITH THE SAME INSULIN PUMP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723350 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR