BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3972329 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88703
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. THE DEVICE PASSED THE FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. NO UNEXPECTED LOW RESERVOIR ALARM OR EXCESSIVE "NO DELIVERY" ALARM NOTED. THE UNIT HAD INTERMITTENT BUTTON RESPONSE DUE TO FLATTEN BUTTONS DOME SWITCHES. THE UNIT WAS RECEIVED WITH BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED STATING HER DAUGHTER'S INSULIN PUMP WAS HAVING KEYPAD ISSUES. THE UP AND DOWN ARROWS OR ACT BUTTON WON'T WORK SOMETIMES. CUSTOMER CAN'T BOLUS BECAUSE OF THE KEYPAD ISSUES. CUSTOMER WAS DISCONNECTED FROM THE DEVICE FOR SOME TIME TODAY BECAUSE SHE WAS PLAYING ON A TRAMPOLINE. CUSTOMER'S BLOOD GLUCOSE WENT UP, BETWEEN 375 MG/DL AND 470 MG/DL. CUSTOMER WAS TAKEN TO THE HOSPITAL, AND HER BLOOD GLUCOSE WAS 470 MG/DL. SHE WAS FEELING NAUSEA. SHE WAS DISCONNECTED FROM DEVICE UPON ARRIVAL. THE DRIVE SUPPORT CAP APPEARS NORMAL. THERE WAS NO AIR IN THE TUBING. INSULIN EXITED DURING MANUAL PRIME. THERE WAS NO LEAK. THE DEVICE HISTORY SHOWED SEVERAL NO DELIVERY ALARMS. THE CANNULA WAS NOT BENT. WHILE ON THE PHONE, CUSTOMER'S MOTHER DROPPED THE DEVICE AND THE CASING WAS CRACKED. SHE WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED. CUSTOMER'S BLOOD GLUCOSE WAS 298 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448575 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization