BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4962235 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24804
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 13, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE PRIME TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS TESTED WITH A TEST TRANSMITTER AND GLUCOSE SENSOR SIMULATOR AND WAS PROGRAMMED WITH MULTIPLE GLUCOSE VALUES. ALL REGISTERED PROPERLY IN THE UPDATE HISTORY. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO UNEXPECTED BOLUS DELIVERY WAS NOTED. NO COSMETIC DAMAGE WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT PARAMEDICS WERE RECENTLY CALLED IN RESPONSE TO A BLOOD GLUCOSE LEVEL OF 21 MG/DL. THE CUSTOMER REPORTED THE SHE WENT TO BED WITH A BLOOD GLUCOSE LEVEL OF 330 MG/DL, THEN LOST CONSCIOUSNESS. CUSTOMER'S HUSBAND CALLED PARAMEDICS WHEN HE FOUND HER UNRESPONSIVE. THE CUSTOMER STATED THAT SHE WAS TREATED BY PARAMEDICS, BUT NOT TRANSPORTED TO A HOSPITAL. THE CUSTOMER STATED THAT REVIEW OF HER BOLUS HISTORY SHOWED THAT SHE RECEIVED TWO UNINTENTIONAL BOLUSES. THE CUSTOMER BEGAN TROUBLESHOOTING, BUT DECLINED TO COMPLETE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 262 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504427 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention