BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933117 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86904
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, SELF AND BASIC OCCLUSION TEST. NO MOTOR ERROR ALARM NOTED. UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. MOTOR PASSED MOTOR TEST. CRACKED RESERVOIR TUBE LIP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING A BASAL, AND THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS 344 MG/DL; THE CUSTOMER'S MOTHER STATED THAT HE TREATED WITH A MANUAL INJECTION. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM OBSERVED. NO SYMPTOMS OF HIGH BLOOD GLUCOSE WERE REPORTED. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE INSULIN PUMP WAS ABLE TO ADMINISTER INSULIN DURING A MANUAL PRIME. NO LEAK WAS FOUND, AND SETTINGS WERE FOUND TO BE CORRECT. TROUBLESHOOTING COULD NOT BE COMPLETED DUE TO THE CUSTOMER NOT HAVING THE TUBING CLAMP. ADVISED DISCONTINUATION OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410490 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR