BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 3918814 · Received June 24, 2014

    Report

    Report Number
    3003442380-2014-00054
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    March 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED DEVICE. THE SOFT CANNULA WAS KINKED AT THE TIP AND MIDDLE. THE FLOW AND LEAK TESTS WERE FOUND WITHIN SPECIFICATIONS. THE VENTILATION TEST CANNOT BE PERFORMED BECAUSE ONLY THE CANNULA WAS RETURNED. DURING MANUFACTURING OF THE CANNULA PART, THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCER NEEDLE. HOWEVER, IF THE INTRODUCER NEEDLE BENT DURING HANDLING AND PACKAGING OF THE INFUSION SET, THIS MAY AFFECT THE SOFT CANNULA CAUSING IT TO KINK. TO PREVENT SYSTEMATIC FAILURES DURING MANUFACTURING, UNOMEDICAL USES ONLINE SAMPLING PLANS ACCORDING TO ISO 2859-1. SAMPLE SIZES ARE TESTED AGAINST SPECIFICATIONS. DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION, THE PATIENT MAY ACCIDENTALLY KINK THE SOFT CANNULA. THIS REPORT HAS ALREADY BEEN REPORTED TO FDA IN THE ASR IN (B)(4), AT THAT TIME WE DID NOT KNOW IF ANYTHING WAS WRONG WITH THE INFUSION DEVICE. UNOMEDICAL A/S HEREBY CONSIDER THIS CASE TO BE CLOSED. USED DEVICE: A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED DEVICE. THE SOFT CANNULA WAS KINKED AT THE TIP AND MIDDLE. THE FLOW AND LEAK TESTS WERE FOUND WITHIN SPECIFICATIONS. THE VENTILATION TEST CANNOT BE PERFORMED BECAUSE ONLY THE CANNULA WAS RETURNED. UNUSED DEVICES: NO UNUSED DEVICE WAS RETURNED FOR INVESTIGATION. REFERENCE SAMPLES: LOT NUMBER UNKNOWN.

    Description of Event or Problem · 1

    (B)(4) 2014 ADDITIONAL DATA: CREATING THIS SVN SINCE THIS IS NOT THE INFUSION SET THAT THE CUSTOMER WAS WEARING WHEN HOSPITALIZED AS HE HAS CHANGED IT SINCE THEN. SEE (B)(4) FOR PUMP DOCUMENTATION INITIAL NOTES: CUSTOMER CALLED IN STATING "I WAS CALLING TO GET A REPLACEMENT PUMP CAUSE I AM IN THE HOSPITAL RIGHT NOW AND MY PHYSICIANS DO NOT BELIEVE THAT IT IS FUNCTIONING PROPERLY." HIGH BG TIS PER DOP. PATIENT'S BG IS 431 MG/DL. BG DETAILS: CUSTOMER IS GOING TO GET A MANUAL INJECTION AND FEELS OKAY TO TROUBLE SHOOT. ADVICE THERE CAN BE MANY REASONS FOR A HIGH BG AND WE WOULD LIKE TO PERFORM SOME TROUBLE SHOOT TO TEST THEIR EQUIPMENT. PATIENT CONTACTED THEIR HEALTH CARE PROVIDER FOR HIGH BGS. CUSTOMER STATES THEY HAVE A BACKUP PLAN. THE PATIENT HAS TREATED FOR HIGH BGS. DETAILS OF TREATMENT ARE AS FOLLOWS: MANUAL INJECTION. PATIENT DOES FEEL OKAY TO TROUBLE SHOOT. CUSTOMER STATES THAT THERE WAS A EMERGENCY ROOM VISIT FOR THEIR HIGH BGS. TIME AND DATE OF EMERGENCY ROOM VISIT WAS: (B)(6) 2014. BG AT TIME OF EMERGENCY ROOM VISIT WAS: UNK. NAME OF THE HOSPITAL: (B)(6). NAME OF INDIVIDUAL REPORTING THE INCIDENT: CUSTOMER. PHONE NUMBER OF THE REPORTER OR HOSPITAL: (B)(6). DESCRIPTION OF THE COMPLAINT: THE ENDO ADVISED THE HOSPITAL IT WAS MILD DKA. SIGNIFICANT EVENTS LEADING TO THE EMERGENCY ROOM VISIT: HIGH BLOOD SUGARS, WEIGHT LOSS, ACHES AND CRAMPING. PATIENT WAS NOT IN AN ACCIDENT. CAUSE OF EMERGENCY ROOM VISIT AS PER HEALTH CARE PROVIDER: DKA. OUTCOME OF THE EMERGENCY ROOM VISIT: INSULIN DRIP. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF EMERGENCY ROOM VISIT. ADVICE CUSTOMER TO DISCONNECT FROM THE PUMP. ADVICE CUSTOMER TO CHECK FOR PROTRUDED, LOOSE, STICKING OUT OR FLUSH DRIVE SUPPORT CAP. CUSTOMER STATES: THE DRIVE SUPPORT CAP APPEARS NORMAL (RECESSED). ADVISED TO DISCONNECT AT QUICK RELEASE OR REMOVE SET FROM BODY. CUSTOMER DISCONNECTED AT QUICK RELEASE. ADVICE TO CHECK THE TUBING FOR AIR. FOUND NO AIR IN TUBING. ASSISTED THE CUSTOMER WITH REMOVING THE RESERVOIR AND REWINDING THE PUMP. ADVICE TO REINSERT RESERVOIR AND RUN A MANUAL PRIME. INSULIN DID EXIT THE TUBING. CUSTOMER REPORTS THEY DID NOT FIND A LEAK. TIME AND DATE ARE CORRECT. CUSTOMER STATES BASAL RATES ARE CORRECT. CUSTOMER STATES BOLUS WIZARD SETTINGS ARE CORRECT. CHECKED ALARM HISTORY. FOUND ONLY LOW RESERVOIR ALARMS AROUND THE TIME OF HOSPITALIZATIONS. CHECKED BOLUS HISTORY. FOUND BOLUS HISTORY IS CORRECT. ADVICE CUSTOMER TO LOCATE THE TUBING CLAMP. ASSISTED WITH PERFORMING THE HP TEST. TEST FAILED TWICE. ADVICE THE PUMP WILL NEED TO BE REPLACED. ADVICE TO RETRIEVE AND SAVE PUMP SETTINGS. ADVICE TO REVERT TO BACKUP PLAN AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTIONS. EXPLAIN OOW REPLACEMENT POLICY. EXPLAIN INTERACTION AFTERCARE EMAIL. THE PATIENT DOES HAVE ANOTHER INFUSION SET AVAILABLE. ADVICE TO REMOVE THE SET FROM THE BODY. THE CANNULA IS BENT. EXPLAIN THAT HIGH BGS ARE OFTEN CAUSED BY SITE/SET ISSUES. REMINDED THE PATIENT TO CHANGE THE SET EVERY 2/3 DAY PER IFU AND CDC GUIDELINES. CUSTOMER STATES THE CANNULA IS OCCLUDED. PATIENT STATES THE SITE IS NOT SORE OR IRRITATED. EXPLAIN THE TWO HIGH BG RULES. ADVICE TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTIONS. ADVICE THE CUSTOMER OF THE INTERACTION AFTERCARE EMAIL. ADVICE AND DIRECTED THE CUSTOMER TO ADDITIONAL RESOURCES AVAILABLE ON OUR WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367224 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MT-397 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization