BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3062045 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01413
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 REPORTED THAT HE WAS HOSPITALIZED AFTER EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HE SLEPT ALL DAY AND DIDN'T EAT THE DAY BEFORE THE HOSPITALIZATION. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS 166 MG/DL WHEN HE WAS ADMITTED. THE CUSTOMER STATED THAT THE SCREEN WAS BLANK WHEN HE WOKE UP. THE CUSTOMER PRESSED THE ACT AND ESC BUTTONS, BUT THE SCREEN REMAINED BLANK. THE CUSTOMER STATED THAT HE WAS LETHARGIC, AND THE PARAMEDICS WERE CALLED. THE CUSTOMER'S WIFE STATED THAT THE SCREEN CAME UP ON ITS OWN, AND THE INSULIN PUMP WAS GIVING A NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ACCURATE. THE INSULIN PUMP WASN'T EXPOSED TO HIGH MAGNETIC FIELDS. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER THAT A BATTERY CAP WOULD BE SENT TO HIM, AND TO CALL BACK AS NEEDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162623 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization