BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4962224 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24720
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY CONTACTED THE HOSPITAL ABOUT THEIR HIGH BLOOD GLUCOSE READINGS. THE BLOOD GLUCOSE READINGS WERE 19 MMOL/L. IT WAS STATED THAT THE PEOPLE WORKING IN THE HOSPITAL BELIEVE THAT THE BASAL IS NOT WORKING. THE CUSTOMER REPLACED THE INSULIN PUMP AND CHANGED THE SET. THE INSULIN PUMP FAILED THE 5 UNITS VIA FIXED PRIME PROCESS BECAUSE THERE WERE NO DROPS. THE INSULIN PUMP DID NOT ALARM OCCLUSION, AND FAILED THE HP TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505248 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1