BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4260177 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-54491
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL. UNABLE TO PERFORM THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME OR NO DELIVERY TESTS DUE TO THE MOTOR ERROR ALARM. THE PUMP ALSO HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, AND A CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THAT THE CUSTOMER WAS ADMITTED IN THE HOSPITAL DUE TO STROKE. THE CUSTOMER UNDERWENT A MAGNETIC RESONANCE IMAGING AND THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 176 MG/DL. . ADVISED THE CUSTOMER TO COMPLETE THE BOLUS DELIVERY BEFORE SENSOR GLUCOSE GRAPH. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746033 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization