BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4780681 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57369
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    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 REPORTED VIA PHONE CALL EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE MANUAL PRIME PROCESS. HE STATED THAT HE TRIED TO PRIME THE INFUSION SET, BUT HE RECEIVED THE ALARM DURING THE FILL TUBING STEP. HE REPORTED THAT THE QUICK RELEASE WAS NOT SECURE. HE STATED THAT HE TREATED WITH SEVERAL BOLUSES THROUGH THE NIGHT TO REGULATE HIS BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 440 MG/DL, WHICH HE ADVISED HE WOULD TREAT ONCE HE GOT THE INSULIN PUMP TO WORK. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE, DISCONNECT THE TUBING AND RESERVOIR, THEN RECONNECT THE TUBING AND RESERVOIR. HE VERIFIED THAT INSULIN EXITED WITH A MANUAL PLUNGER PUSH. HE WAS ADVISED TO REWIND THE DEVICE, REINSERT THE RESERVOIR AND RUN A MANUAL PRIME TO AT LEAST 5.0 UNITS. HE STATED THAT THE INSULIN PUMP DID NOT ALARM ON DELIVERY AND WAS ADVISED THAT THE INSULIN PUMP WORKED AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325256 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR