BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 3918811 · Received June 24, 2014

    Report

    Report Number
    3003442380-2014-00056
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    March 17, 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

    USED DEVICE: A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICES. THE PCC CONNECTOR NEEDLE WAS CLOGGED BY INSULIN ON ONE OUT OF TWO. VISUAL, LEAK AND VENTILATION TO PCC CONNECTOR TEST RESULTS WERE WITHIN SPECIFICATIONS. UNUSED DEVICES: A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED UNUSED DEVICES 2 SETS. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICES. THE PCC CONNECTOR NEEDLE WAS CLOGGED BY INSULIN ON ONE OUT OF TWO. VISUAL, LEAK AND VENTILATION TO PCC CONNECTOR TEST RESULTS WERE WITHIN SPECIFICATIONS. A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND VENTILATION TO PCC CONNECTOR WERE PERFORMED ON THE RETURNED UNUSED DEVICES 2 SETS. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DURING MANUFACTURING THE INFUSION SETS ARE 100% FLOW TESTED BY BUILT-IN CONTROLS IN THE MACHINES OR MANUALLY PERFORMED FLOW TESTING. IF THE DEVICES ARE UNDERGOING MANUAL FLOW TESTING, HUMAN ERROR DURING TESTING CAN OCCUR. CAUSE FOR OCCLUSION CAN BE EXCESSIVE AMOUNTS OF GLUE BLOCKING THE PCC CONNECTOR NEEDLE. DURING USE MEDICATION CAN ALSO CRYSTALIZE AND CAUSED OCCLUSIONS. TO PREVENT SYSTEMATIC FAILURES DURING MANUFACTURING, UNOMEDICAL USES ONLINE SAMPLING PLANS ACCORDING TO ISO 2859-1. SAMPLE SIZES ARE TESTED AGAINST SPECIFICATIONS. THE SET HAS WORKED AS INTENDED. THE PUMP HAS GIVEN THE NO DELIVERY ALARM TO TELL THE PATIENT THAT THE SET IS OCCLUDED. THIS REPORT HAS ALREADY BEEN REPORTED TO FDA IN THE (B)(4), AT THAT TIME WE DID NOT KNOW IF ANYTHING WAS WRONG WITH THE INFUSION DEVICE. UNOMEDICAL (B)(4) HEREBY CONSIDERS THIS CASE TO BE CLOSED. REFERENCE SAMPLES: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND VENTILATION TO THE PCC RESERVOIR CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    (B)(6) 2014 INITIAL NOTES: CUSTOMER'S FATHER (B)(6) CALLING IN BECAUSE HIS DAUGHTER WENT TO THE ER YESTERDAY DUE TO HIGH BG, AND ALL OF HER CANNULAS HAVE BEEN BENT WHEN SHE PULLS THEM OUT. HIGH BG T IS PER DOP. PATIENT'S BG IS 352 MG/DL. BG DETAILS: YES, MANUAL INJECTIONS. ADVICE THERE CAN BE MANY REASONS FOR A HIGH BG AND WE WOULD LIKE TO PERFORM SOME TROUBLE SHOOT TO TEST THEIR EQUIPMENT. PATIENT EXPRESSED THE FOLLOWING SYMPTOMS OF HIGH BGS: STOMACH ACHE. 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: IV, FLUIDS. PATIENT DOES FEEL OKAY TO TROUBLE SHOOT. REVIEWED ACCOUNT HISTORY FOR SIMILAR COMPLAINTS IN RECENT HISTORY. CUSTOMER DOES NOT HAVE ANY OTHER HISTORY OF COMPLAINTS. CUSTOMER STATES THAT THERE WAS AN 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: 442. NAME OF THE HOSPITAL: (B)(6). NAME OF INDIVIDUAL REPORTING THE INCIDENT: (B)(6). PHONE NUMBER OF THE REPORTER OR HOSPITAL: (B)(6). DESCRIPTION OF THE COMPLAINT: HIGH BG. SIGNIFICANT EVENTS LEADING TO THE EMERGENCY ROOM VISIT: STOMACH ACHE, HIGH KETONES, PATIENT WAS NOT IN AN ACCIDENT. CAUSE OF EMERGENCY ROOM VISIT AS PER HEALTH CARE PROVIDER: FOR SEVERAL DAYS HIGH BG. OUTCOME OF THE EMERGENCY ROOM VISIT: DISCHARGED AND NOT HOSPITALIZED. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF EMERGENCY ROOM VISIT. SHE WAS TREATED AT ER FOR HIGH BG WITH IV FLUIDS, AND HER BG WAS 250 WHEN SHE LEFT. THEY REFERRED HER TO HER ENDOCRINOLOGIST. ENDOCRINOLOGIST ADVISED TO CHANGE HER SET OUT AND TO TRY A DIFFERENT BOX. SUGGESTED TO PARENTS TO GIVE HER A MANUAL INJECTION. ADVICE CUSTOMER TO DISCONNECT FROM THE PUMP. ADVISED 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 REMOVED SET FROM BODY. ADVICE TO CHECK THE TUBING FOR AIR. FOUND NO AIR. 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 FMD A LEAK. TIME AND DATE ARE CORRECT. CUSTOMER STATES BASAL RATES ARE CORRECT. CUSTOMER STATES BOLUS WIZARD SETTINGS ARE CORRECT. CHECKED ALARM HISTORY. FOUND NO DELIVERY ALARMS. DAD SAYS SHE HAS BEEN HAVING BENT CANNULA , CHECKED BOLUS HISTORY. FOUND APPEARS CORRECT. ADVICE CUSTOMER TO LOCATE THE TUBING CLAMP. ASSISTED WITH PERFORMING THE HP TEST. TEST PASSED. ADVICE CUSTOMER THE PUMP IS WORKING AS DESIGNED. EXPLAIN THE TWO HIGH BG RULE. ADVICE TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTHCARE PROVIDER'S INSTRUCTIONS. ASSISTED WITH RESETTING THE FIXED PRIME. EXPLAINED THE INTERACTION AFTERCARE EMAIL ADVICE AND DIRECTED THE CUSTOMER TO ADDITIONAL RESOURCES ON OUR WEBSITE. 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 HAS NOT BEEN CHANGING HER SET EVERY 2/3 DAYS SHE HAS BEEN GOING EVERY 3/4 DAYS. CUSTOMER STATES THE CANNULA IS NOT OCCLUDED. PATIENT STATES THE SITE IS NOT SORE OR IRRITATED. EXPLAIN THE TWO HIGH BG RULE. 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. ADVICE THE PATIENT TO CHECK THE INSULIN VIAL FOUND: CLEAR AND NOT EXPIRED. EXPLAIN IF INSULIN HAS EXPIRED, OR PUMP/SET/RESERVOIR HAS BEEN EXPOSED TO HIGH TEMPS OR DIRECT SUNLIGHT, TO CHANGE SET/RESERVOIR AND INSULIN. ADDITIONAL NOTES: LOT#: 5044258. RESERVOIR: (B)(4), LOT#: H9225699 SHE HAS BEEN CHANGING HER SET EVERY 3 TO 4 DAYS NOT EVERY 2 TO 3 DAYS. CUSTOMER THINKS THAT THERE IS AN ISSUE WITH THESE INFUSION SETS BECAUSE SHE KEEPS GETTING BENT CANNULAS AND SHE HAS BEEN USING THE QUICK SET FOR 3 YEARS. ADVISED CUSTOMER TO TRY SOME QUICK SETS FROM A DIFFERENT LOT NUMBER WHICH I WILL SEND. I WILL ALSO SEND SAMPLES OF THE SURE-T, AND THE SILHOUETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367223 QUICK-SET PARADIGM QUICK-SET PCC FPA UNOMEDICAL A/S MMT-399 5044258

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization