BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141704 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33276
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE CUSTOMER HAD A LOW SUSPEND ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 117 MG/DL. CUSTOMER HAD TROUBLE WITH SENSORS AND STATED THAT LAST WEEK SHE WAS IN KETOSIS. CUSTOMER STATED THAT THE SENSOR KEPT SAYING HER BLOOD GLUCOSE LEVEL WAS LOW AND IT TURNED OFF THE PUMP. CUSTOMER VOLUNTARILY TURNED THE SENSOR OFF AND TURNED IT BACK ON AGAIN. CUSTOMER CHOSE TO KEEP THE PUMP OFF FOR 45 MINUTES AND WHEN SHE GOT HOME FROM WORK, SHE HAD A REALLY BAD HEADACHE AND STOMACH AND MUSCLE PAIN. CUSTOMER BOLUSED WITH THE PUMP, WHICH DID NOT WORK AND THEN BOLUSED WITH SYRINGES. WHEN CUSTOMER GOT HOME FROM WORK, SHE WAS IN FULL FLEDGED KETOSIS AND COULD NOT MOVE. CUSTOMER DID NOT GO TO THE HOSPITAL, BUT STATED SHE SHOULD HAVE. CUSTOMER TOOK EVERYTHING OFF AND JUST STARTED USING THE PUMP AGAIN. CUSTOMER DECLINED TROUBLESHOOTING AND STATED HER BLOOD GLUCOSE LEVELS WERE HIGH. CUSTOMER DECLINED TROUBLESHOOTING FOR CAL ERROR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621151 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR