BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240512 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49729
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 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

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. PLEASE SEE MEDWATCH REPORT # 2032227-2014-36467

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP DID NOT PICK UP THE GLUCOMETER SIGNAL DUE TO THE METER SETUP. THE BLOOD GLUCOSE READING WAS 380 MG/DL. THE CUSTOMER STATED THAT HE HAD STARTED EXPERIENCING THE METER COMMUNICATION ISSUE ABOUT A WEEK PRIOR. HE ALSO NOTED THAT HE HAD HAD LASER SURGERY AND DID NOT KNOW WHETHER THAT WOULD AFFECT HIS BLOOD GLUCOSE LEVELS. HE ADVISED THAT HIS BLOOD GLUCOSE LEVELS SHOULD BE HIGH SINCE HE HAD JUST EATEN. DURING TROUBLESHOOTING, THE CUSTOMER STATED THAT THE ISSUE WAS NOT WITH THE INSULIN PUMP. HE ADVISED THAT THE BLOOD GLUCOSE VALUE HAD TRANSFERRED OVER TO THE INSULIN PUMP AND THAT NO FURTHER ASSISTANCE WAS NECESSARY. ADVISED HIM TO CONSULT HIS DOCTOR ABOUT ANY OF THE SURGERY EFFECTS ON HIS BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723578 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR