BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4143401 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30136
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARM NOTED. THE DEVICE PASSED THE FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. NO EXCESSIVE "NO DELIVERY" ALARM NOTED. THE UNIT WAS PROGRAMMED WITH MULTIPLE BOLUSES AND BASAL RATES AND MONITORED. THE BOLUSES AND BASAL RATES WERE DELIVERED AND RECORDED PROPERLY. THE DAILY TOTALS CALCULATED THE AMOUNTS OF UNITS DELIVERED AND IT WAS CORRECT. NO DELIVERY ANOMALY OR UNEXPECTED BOLUS DELIVERY NOTED. THE TRACES AND HISTORY DOWN LOAD FILES SHOWED 25 UNITS BOLUS BEING PROGRAMMED AND DELIVERED ON (B)(4) 2014 AT 11:26 AM. THE EVENT HISTORY FILE WAS OVERWRITTEN. UNABLE TO VERIFY IF CUSTOMER WAS MANUALLY PROGRAMMED PUMP 25UNITS BOLUS. NO COSMETIC DAMAGE NOTED.

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS OF ABOUT 26 MG/DL. THE CUSTOMER TREATED WITH GLUCOSE TABLETS AND MILK. THE CUSTOMER REPORTED THAT TWENTY-FIVE UNITS OF INSULIN WERE DELIVERED WITHOUT THE CUSTOMER'S KNOWLEDGE. THE DELIVERY OF INSULIN WAS RECORDED IN THE HISTORY OF THE INSULIN PUMP. THE CUSTOMER WOULD LIKE TO PARTICIPATE IN THE VOLUNTARY RECALL OF THE INSULIN PUMP. MEDTRONIC HAS INFORMED CUSTOMERS OF THE POTENTIAL TO DELIVER INSULIN THROUGH ACCIDENTAL BUTTON PUSHING THOUGH A SAFETY NOTIFICATION LETTER THUS THE VOLUNTARY RECALL. THE CUSTOMER REPORTED THE POSSIBILITY OF HAVING ACCIDENTALLY PRESSED THE BUTTON THAT GAVE HER A MAX BOLUS FROM THE INSULIN PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603430 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR