BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3150909 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-94491
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND BOLUS DELIVERY. NO MOTOR ERROR ALARMS OCCURRED DURING TEST. MOTOR TEST PASSED. THE INSULIN PUMP WAS RETURNED WITH A BROKEN RESERVOIR TUBE LIP, MISSING O-RING RESERVOIR TUBE, CRACKED RESERVOIR TUBE AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 525MG/DL. THE CALLER STATED THAT THE DEVICE ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CUSTOMER TO RUN A SELF TEST AND PASSED. THE DISPLACEMENT TEST COULD NOT BE PERFORMED AS CUSTOMER DID NOT HAVE ANY SUPPLIES. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249750 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization