BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942573 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04504
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING PRIME/A33 ALARM TEST AND MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. MOTOR TESTED OKAY. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND MISSING END CAP STICKER NOTED DURING VISUAL INSPECTION. UNABLE TO PRIME DURING PRIME/A33 ALARM TEST AND MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. MOTOR TESTED OKAY. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND MISSING END CAP STICKER NOTED DURING VISUAL INSPECTION.

    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.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT A MOTOR ERROR ALARM DURING BREAKFAST. THE REPORTED BG AT THE TIME OF THE CALL WAS 109 MG/DL. TROUBLESHOOTING WAS PERFORMED. NO EXPOSURE TO HIGH MAGNETIC FIELDS REPORTED. THE PATIENT WAS UNABLE TO REWIND THE PUMP. ADVISED THE PATIENT THAT THE PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418320 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR