BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3110041 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01909
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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

    THE CUSTOMER CALLED BECAUSE HE FELT THAT THE INSULIN PUMP WAS DELIVERING INSULIN ON ITS OWN. THE CUSTOMER ALSO STATED THAT HE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT PROVIDE A BLOOD GLUCOSE READING FOR THE ADMISSION. THE CUSTOMER STATED THAT HE OFTEN EXPERIENCES LOW BLOOD GLUCOSE LEVELS, AND IT'S SOMEWHAT NORMAL FOR HIM. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. FOUND NO DELIVERY ALARMS IN THE ALARM HISTORY. THE RESERVOIR VOLUME WAS ACCURATE. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING AS HIS BLOOD GLUCOSE LEVELS ARE NORMAL. THE CUSTOMER DID STATE THAT HE SAW NUMBERS RAMPING UP ON THEIR OWN WHILE HE WAS DRIVING, BUT ACKNOWLEDGED THE POSSIBILITY OF THE BUTTONS ACCIDENTALLY BEING PRESSED. ADVISED THE CUSTOMER OF THE KEYPAD LOCK FEATURE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211174 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization