BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3930511 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86720
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSULIN IS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. HE WAS TRYING TO PUT IN A NEW INFUSION SET AND THE INSULIN PUMP PUSHED OUT ONE HUNDRED UNITS OF INSULIN. CUSTOMER STATED THAT INSULIN CONTINUES TO DRIP OUT AFTER HE LETS GO OF THE ACT BUTTON DURING THE PRIME PROCESS. CUSTOMER WAS NOT WEARING THE DEVICE DURING THE PRIMING PROCESS. THE TUBING CONNECTOR OR TOP OF THE RESERVOIR WAS NOT WET WITH ANY LIQUID. CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR AND TRIED TO PRIME AGAIN. INSULIN DID NOT CONTINUE TO DRIP AFTER LETTING GO OF THE ACT BUTTON. THE MOTOR DID NOT SLOW DOWN AND THE NUMBERS DID NOT RAMP UP ON THE SCREEN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. EXPLAINED THAT THE FORCE SENSOR DID NOT DETECT RESERVOIR DURING THE SEATING PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 215 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408921 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR