BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7633823 · Received June 25, 2018

    Report

    Report Number
    3004209178-2018-84829
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    May 26, 2018
    Report Date
    August 20, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169476660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    COMPLAINTS TEXT (B)(6) 2018, ERP_RFC_USER RELATED (B)(4). COMPLAINTS TEXT (B)(6) 2018, (B)(6). CUSTOMER INITIALLY CALLED BEFORE TROUBLESHOOTING. SEE (B)(4). COMPLAINTS TEXT (B)(6) 2018, ERP_RFC_USER RELATED (B)(4). COMPLAINTS TEXT (B)(6) 2018, (B)(6) UPDATED ADDRESS: (B)(6). COMPLAINTS TEXT (B)(6) 2018, (B)(6). INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: HE INSERTED A SET ON FRIDAY AND BY THE NEXT MORNING HIS BG WAS 202 SO HE BOLUSED AND ATE BREAKFAST. HE WENT TO WORK AND HIS BG AT 830AM THAT MORNING WAS 600. HE GAVE HIMSELF A MANUAL INJECTION BUT HIS BG DID NOT DECREASE. HE REMOVED HIS SET LATER WHEN HE MADE IT HOME AND NOTICED THAT THE CANNULA WAS KINKED. HE INSERTED ANOTHER SET ON THE OPPOSITE SIDE OF HIS STOMACH. HE BOLUSED AND IT DELIVERED SUCCESSFULLY. HE ATE LUNCH LATER IN THE DAY AND EXPERIENCED ANOTHER NO DELIVERY ALARM. HE CHANGE HIS SET AND NOTICED ANOTHER KINKED CANNULA. BENT CANNULA TROUBLESHOOTING PER (B)(4). CUSTOMER REPORTS THE INFUSION SET CANNULA IS: BENT. SITE LOCATION: ABDOMEN INQUIRED IF CUSTOMER STANDS UPRIGHT WHEN INSERTING INFUSION SET. FOUND: STANDS AND SITS INQUIRED IF CUSTOMER HAS SUFFICIENT SUB-Q TISSUE WHERE SET IS INSERTED. FOUND: YES SET INSERTION METHOD USED: MANUALLY INQUIRED IF CUSTOMER HAS ISSUES WITH SCARRED TISSUE, HARDENED TISSUE OR STRETCH MARKS. FOUND: NO WHEN BENT CANNULA OCCURRED: NOTICES UPON REMOVAL. LENGTH OF TIME INFUSION SET HAS BEEN IN USE: LESS THAN 24 HOURS INQUIRED IF CUSTOMER HAD ANY ISSUES WITH TAPE NOT ADHERING. FOUND: NO MMT-387 LOT 5203697 ADV AN INF WITH A LONGER CANNULA MAY BEND AGAINST MUSCLE ON LEAN CUSTOMERS. ADV IF THE NEEDLE IS REMOVED WHEN THE INF IS NOT FLUSH WITH THE SKIN YOU CAN LOSE RIGIDITY AND SUPPORT FOR THE CANNULA. ADV HANDLING INF PER GUIDELINES WILL HELP AVOID POTENTIAL KINKS OR BENDS TO CANNULA, E.G. SLOWLY REMOVING ADHESIVE TAPE LINER AND NEEDLE GUARD DURING PREPARATION AND INSERTION PROCESS. ADV IF THE SET IS INSERTED IN AREAS WHERE CLOTHING MIGHT CAUSE IRRITATION (BELTLINE, ETC.) THIS MAY LEAD TO BENT CANNULAS. ADV IF THE SET IS INSERTED INTO THE 2-INCH AREA AROUND THE BELLY BUTTON REGION IT MAY RESULT IN BENT CANNULAS. EXPLAIN THE INFUSION SET SHOULD BE 2 INCHES AWAY FROM THE BELLY BUTTON REGION AND 3 INCHES AWAY FROM THE PREVIOUS INSERTION SITE. ITEM - 'ADVISE CUSTOMER TO CHANGE AND RETURN THE INFUSION SET' REASON NOT COMPLETED - CUSTOMER STATED THAT HE CHANGED HIS INFUSION SET FOR THE 3RD TIME AND IT WAS WORKING CORRECTLY.. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: ADVISED CUSTOMER THAT WE WILL SHIP REPLACEMENT SETS IN RETURN FOR HIS ITEMS. ADDITIONAL NOTES: CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BGS. SHIP: 1 MMT-387 (BOX) / RETURN: 2 MMT-387 (EACH) REASON FOR RETURN: BENT CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477278 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAP A0723RNAPJ 00643169476660

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other INFST MMT-387 QCKSTPRDGM 10PK 6MM32N