BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2905088 · Received January 9, 2013

    Report

    Report Number
    2032227-2013-00082
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP DID HAVE CRACKED BATTERY TUBE THREADS AND A SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 20 MG/DL. THE CAUSE OF THE LOW BLOOD GLUCOSE LEVELS WAS UNKNOWN. IT WAS STATED THAT THE PARAMEDICS WERE UNABLE TO GET AN IV INTO THE CUSTOMER'S ARM, AND TOOK HIM TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED, AND ALL OF THE PROGRAMMING WAS CORRECT. THE CALLER STATED THAT THE INSULIN PUMP WAS EXPOSED TO X-RAYS IN THE PAST. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CALLER STATED THAT THE CUSTOMER MAY ALSO HAVE PNEUMONIA. IT WAS STATED THAT THE CUSTOMER WAS TAKING MEDICATION FOR ON ABSCESS ON HIS LEG. THE CUSTOMER IS ALSO ON MEDICATION FOR PARKINSONS, AND FREQUENTLY EXPERIENCES SEIZURES. FOUND THAT THE CUSTOMER'S FIXED PRIME AMOUNT WAS SET TO 3.0, WHICH WAS INCORRECT. ASSISTED WITH THE CORRECT AMOUNT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE X-RAY EXPOSURE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10481 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization