BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3982057 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89812
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER HAD BEEN HAVING HIGH BLOOD GLUCOSE AND THAT THERE WAS AN AIR BUBBLE IN THE RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE WAS 521 MG/DL AT THE TIME THE EVENT WAS REPORTED AND WAS TREATED WITH A MANUAL INJECTION. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER'S SYMPTOM OF HIGH BLOOD GLUCOSE WAS THIRST AND THAT THE SITE HAD BEEN MORE RED LATELY THAN USUAL. DURING TROUBLESHOOTING, THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. THERE WAS AN AIR BUBBLE FOUND IN THE RESERVOIR. NO LEAKS WERE FOUND, THE TIME AND DATE WERE CORRECT, AND BOLUSES WERE RECORDED CORRECTLY IN THE INSULIN PUMP. THE CANNULA WAS NOT BENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456588 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH A2551NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention