BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141832 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33614
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME TEST AND DISPLACEMENT TEST. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK ON A MOTOR ERROR ALARM THAT OCCURRED DURING THE BOLUS OR BASAL DELIVERY. NO MOTOR POSITION ENCODER ERROR ALARM COULD BE CONFIRMED DUE TO AN ERASED HISTORY FILE AND ALARMS FOR CORRUPTED HISTORY FILES. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A MOTOR ERROR ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 105 MG/DL. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM AND WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER STATED THAT HE WAS UNABLE TO COMPLETE THE REWIND SEQUENCE. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REMOVE THE PUMP BATTERY TO PREVENT CONTINUED ALARMS. CUSTOMER WAS ALSO ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621597 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR