BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4153386 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-25731
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 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 FAMILY MEMBER OR FRIEND

    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 BOLUS WIZARD DID NOT CALCULATE CORRECTLY. THE BLOOD GLUCOSE READING WAS 172 MG/DL. THE CUSTOMER'S FATHER STATED THAT THE BOLUS CALCULATION WAS NOT ADJUSTING BASED ON THE PARAMETERS PROVIDED. HE REPORTED THAT THE FOOD AND CORRECTION BOLUS WERE INCORRECT, STATING THE THAT DEVICE WAS NOT SUBTRACTING THE ACTIVE BOLUS. ADVISED THE CUSTOMER THAT ADJUSTING THE BOLUS ESTIMATE MAY CAUSE HIGH OR LOW BLOOD GLUCOSE LEVELS. THE CALLER BECAME FRUSTRATED DURING THE CALL DURING A REQUEST FOR MORE INFORMATION. UNABLE TO REACH THE CUSTOMER TO EXPLAIN THAT IF THE BLOOD GLUCOSE WAS NOT ENTERED ALONG WITH THE FOOD CORRECTION VALUE, THEN THE INSULIN PUMP WOULD NOT SUBTRACT THE ACTIVE INSULIN. THE N/A INDICATOR ON THE INSULIN PUMP, WHICH THE CALLER HAD OBSERVED, WAS A NORMAL FUNCTION OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630733 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR