BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3951345 · Received July 22, 2014

    Report

    Report Number
    2032227-2014-04763
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE DOWNLOAD HISTORY FILES SHOW MULTIPLE ERROR ALARMS DUE TO CORRUPTED HISTORY FILES. UNABLE TO VERIFY BOLUS ANOMALY OF 14.6 UNITS DUE TO THE CORRUPTED HISTORY FILES. THE DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND THE EXCESSIVE NO DELIVERY TEST. THE DEVICE WAS PROGRAMMED WITH SEVERAL BOLUSES AND MONITORED. ALL BOLUSES WERE DELIVERED AND WERE LISTED IN THE BOLUS HISTORY SCREEN. THE UNIT THEN WAS PROGRAMMED WITH MULTIPLE BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED PROPERLY THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY TOTAL SCREEN. NO UNEXPECTED BOLUS DELIVERY NOTED DURING TESTING. NO DELIVERY ANOMALY, DAILY TOTAL ANOMALY, BASAL ANOMALY OR BOLUS ANOMALY NOTED. THE UNIT HAD CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS ADMITTED FOR IN-PATIENT MEDICAL TREATMENT WITH A BLOOD GLUCOSE LEVEL OF 46 MG/DL. THE REASON FOR LOW BLOOD GLUCOSE, AS REPORTED BY THE PATIENT, WAS A BOLUS DELIVERY FROM THE CUSTOMER'S INSULIN PUMP THAT HE DID NOT PROGRAM. AT THE TIME OF THE REPORT, THE CUSTOMER'S BLOOD GLUCOSE WAS AT 375 MG/DL, FOLLOWING THE PARAMEDICS TREATING HIM INTRAVENOUSLY WITH SUGAR WATER. TROUBLESHOOTING WITH THE INSULIN PUMP WAS PERFORMED. PROGRAMMING WAS REVIEWED AND IT WAS FOUND THAT THE BOLUS LEADING TO THE HOSPITALIZATION WAS ACCURATE AND THE CUSTOMER'S DOCTOR CONFIRMED THE BASAL PROGRAMMING WAS CORRECT. THE INSULIN IN THE RESERVOIR MATCHED WHAT WAS SHOWN ON THE INSULIN PUMP'S STATUS SCREEN. BOLUS WIZARD SETTINGS WERE FOUND TO BE ACCURATE. THE CUSTOMER STATES HIS LAST BOLUS WAS DELIVERED AT 2:40AM, BUT BECAUSE HIS CLOCK WAS AHEAD BY AN HOUR, IT WAS DELIVERED TO HIS BODY AT 1:40AM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428694 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization