BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL

    MDR report key: 6657789 · Received June 21, 2017

    Report

    Report Number
    2032227-2017-22423
    Event Type
    Injury
    Date Received
    June 21, 2017
    Date of Event
    May 21, 2017
    Report Date
    August 2, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169202375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST AND REWIND TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED. NO SMELL INSULIN ON PUMP NOTED. NO MOISTURE DAMAGE ON ELECTRONICS AND MOTOR NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE. A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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 VIA PHONE CALL THAT HER INSULIN PUMP HAS BEEN HAVING ISSUES FOR THE PAST 3 DAYS. SHE HAS BEEN TRYING TO GET HER BLOOD GLUCOSE LEVELS DOWN AND HAS TRIED EVERYTHING. THE LAST THING SHE TRIED WAS TO TAKE OUT HER RESERVOIR FROM THE PUMP AND STATED THAT THE RESERVOIR COMPARTMENT SMELLED LIKE INSULIN. THE CUSTOMER SAID SHE WAS DOING LAUNDRY AND HER INSULIN PUMP FELL OFF OF HER BELT AND HIT THE FLOOR REALLY HARD ON (B)(6) 2017. HER BLOOD GLUCOSE WAS 91 MG/DL, WHICH WAS TREATED WITH A MANUAL INJECTION. THERE WAS A HAIR LINE FRACTURE ON THE INSIDE THE BASE OF HER RESERVOIR. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE RANGE HAS BEEN FROM 200 ¿ 438 MG/DL AND SHE TREATED WITH A MANUAL INJECTION. SHE SAID THAT THIS MORNING SHE CHANGED THE SET. HOWEVER, THE RESERVOIR COMPARTMENT STILL SMELLED LIKE INSULIN. HER CURRENT BLOOD GLUCOSE, AT THE TIME OF THE CALL, WAS 229 MG/DL. DURING PUMP EXPOSED TO FLUID TROUBLESHOOTING, CUSTOMER REVIEWED THE ALARM HISTORY, THERE HAVE BEEN SIX NO DELIVERY ALARMS SINCE (B)(6) 2017. ASSISTED THE CUSTOMER IN PERFORMING A SELF-TEST AND THE PUMP PASSED. DURING TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE, CUSTOMER SAID THAT HER HEART AND EYES WERE HURTING AND THAT SHE TREATED WITH A MANUAL INJECTION. SHE WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TO REVERT TO A BACKUP PLAN. THE CUSTOMER STOPPED THE TROUBLESHOOTING BECAUSE SHE WASN'T FEELING WELL. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438526 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL B1723NALJ 00643169202375

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other