BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241495 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50532
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST. NO UNEXPECTED MAX DELIVERY ALARM NOTED. UNIT WAS PROGRAMMED WITH SEVERAL BOLUSES AND MONITORED. THE UNIT CALCULATED THE ADDITIONAL BOLUS DELIVERIES AND WAS VERIFIED IN THE DAILY TOTAL 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 DAILY TOTAL ANOMALY, BASAL ANOMALY OR BOLUS ANOMALY NOTED. THE UNIT HAD A MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 FOR SLIGHT DIABETES KETOACIDOSIS AND A BLOOD GLUCOSE LEVEL OF 696 MG/DL. THE CUSTOMER EXPRESSED THE FOLLOWING SYMPTOMS: FREQUENT URINATION, THIRST, AND MALAISE. THE CUSTOMER DROVE HIMSELF TO THE HOSPITAL AND WAS TREATED WITH AN IV. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HIS HOSPITALIZATION. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE REPORT WAS 600 MG/DL WHICH HE TREATED WITH A MANUAL INJECTION. HE STATED HIS INSULIN PUMP IS NOT DISPENSING THE PROPER AMOUNT OF INSULIN. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO CHANGE HIS RESERVOIR, INFUSION SET, AND INSULIN. THE INSULIN PUMP FUNCTIONED ACCORDING TO SPECIFICATION. THE CUSTOMER'S HEALTH CARE PROVIDER WOULD LIKE THE INSULIN PUMP TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722369 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization