BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873344 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85773
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    IT WAS REPORTED BY THE CUSTOMER THAT SHE HAD BEEN HAVING HIGH BLOOD GLUCOSE LEVELS. BLOOD GLUCOSE LEVELS HAVE REACHED AS HIGH AS 600 MG/DL IN THE EARLY MORNING. CUSTOMER ALSO STATED THAT THE THRESHOLD SUSPEND HAD NOT ALARMED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. INSULIN EXITED TUBING. ASSISTED IN VERIFYING CORRECTNESS OF TIME, DATE AND BOLUS SETTINGS. WHILE CHECKING ALARM HISTORY, IT WAS DISCOVERED THAT THERE WAS A LOW THRESHOLD ALARM BUT PRIOR TO (B)(6) OF 2014. IT WAS ALSO DISCOVERED THAT CUSTOMER WAS ONLY ALLOWED FOUR UNITS OF INSULIN EACH MEAL, REGARDLESS OF WHAT SHE HAD EATEN BEFORE SLEEPING. BLOOD GLUCOSE LEVEL WAS 149 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349566 530G INSULIN PUMP OYZ OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR