BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170414 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37933
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONICS, MOTOR, VIBRATOR MOTOR, OR BATTERY TUBE ASSEMBLY. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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. (B)(4). REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-37925.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HAVING IRREGULAR READINGS ON HER INSULIN PUMP. SHE ALSO STATED SHE HAD GONE INTO THE POOL WITH HER INSULIN PUMP, WHICH LED HER TO HAVE IRREGULAR READINGS ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED SHE DID NOT NOTICE FREQUENT ALARMS SINCE DAMAGING HER INSULIN PUMP. IT WAS FOUND THE INSULIN PUMP PASSED THE SELF TEST DURING TROUBLESHOOTING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651853 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR