BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3954153 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-88109
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TEST. NO BOLUS ANOMALY OR BASAL ANOMALY WERE NOTED DURING THE TESTING. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP.

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING PROBLEMS WITH HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 487 MG/DL. THE CUSTOMER STATED THAT WHEN THEY ARE CONNECTED TO THE INSULIN PUMP THERE ARE KINKS AND THE INSULIN IS NOT BEING DELIVERED. THE CUSTOMER WAS OFFERED TROUBLESHOOTING BUT THEY DECLINED, STATING THAT THEY ALREADY DID TROUBLESHOOTING FOR THE SAME REASON AND WERE STILL HAVING HIGH BLOOD GLUCOSE. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430657 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR