BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5994269 · Received October 3, 2016

    Report

    Report Number
    2032227-2016-23048
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    October 18, 2013
    Report Date
    October 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED ON MOTOR HOME SWITCH. NO MOISTURE DAMAGE WAS FOUND ON ELECTRONIC ASSY. THE PUMP WAS UNABLE TO VERIFY THE MOTOR POSITION ENCODER ERROR ALARM DUE TO MOTOR ERROR. THE PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 214 MG/DL. THE CUSTOMER STATED THAT THE PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. THE CUSTOMER WAS ADVISED TO CHECK IF THE DRIVE SUPPORT CAP IS PROTRUDED, LOOSE, STICKING OUT OR FLUSH. THE CUSTOMER REPORTED THE DRIVE SUPPORT CAP TO APPEAR NORMAL. THE CUSTOMER STATED THAT THERE WAS A MOTOR POSITION ENCODER ERROR IN THE ALARM HISTORY. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WILL BE SENT A REPLACEMENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644589 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 37 YR