BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4062073 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-17189
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    June 1, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP ALARMED FOR A FAILED BATTERY TEST AFTER BATTERY INSERTION DUE TO A FAULTY BATTERY TUBE. THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TEST COULD NOT BE PERFORMED DUE TO THE FAILED BATTERY TEST ALARM. NO HISTORY ANOMALY COULD BE TESTED AND NO UPLOAD COULD BE PERFORMED DUE TO THE FAILED BATTERY TEST ALARM. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE AND A CRACKED RESERVOIR TUBE LIP. THE INSULIN PUMP WAS RECEIVED WITHOUT THE BELT CLIP AND NO DAMAGE TO THE BELT CLIP COULD BE VERIFIED. NO DAMAGE WAS NOTED ON THE BELT CLIP SLOT.

    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

    CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WOULD DROP AFTER SHE CHANGES THE INFUSION SET. SHE REPORTED THAT SHE EXPERIENCES LOW BLOOD GLUCOSE MORE FREQUENTLY SINCE USING THE INSULIN PUMP, AS LOW AS 45 MG/DL. SHE ALSO REPORTED THAT THE DISPLAY HAD GONE BLANK ON THE INSULIN PUMP. SHE STATED THAT SHE WAS TREATING WITH MANUAL INJECTIONS. THE BLOOD GLUCOSE READING AT THE TIME OF THE REPORT WAS 148 MG/DL. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED OR BUMPED BUT HAD BEEN EXPOSED TO SWEAT. SHE STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR CORRODED AND THAT THE BATTERY COMPARTMENT AND SPRING WERE NOT CORRODED OR DAMAGED. THROUGH TROUBLESHOOTING, THE DISPLAY STILL DID NOT RETURN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542235 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention