BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3072644 · Received April 23, 2013

    Report

    Report Number
    2183996-2013-00729
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 7, 2013
    Report Date
    August 1, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY ON THE INFUSION SET CANNOT BE VERIFIED, THE MATERIAL MEETS PRODUCT SPECIFICATIONS. RESULT NO SAMPLE WAS RECEIVED FOR EXAMINATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK, FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED HAVING A POSSIBLE LEAK WHILE USING THE INFUSION SET. PATIENT STATED SHE IS EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS. PATIENT USES A COMPETITOR'S BLOOD GLUCOSE MONITOR. PATIENT REPORTED SHE CHECKED THE LUER, CONNECTORS, INFUSION SET TUBING AND INFUSION SITE; IS NOT SURE OF THE EXACT AREA WHERE THE LEAK OCCURRED. PATIENT STATED SHE DOES NOT KNOW WHERE THE LEAK ORIGINATED. PATIENT REPORTED SHE HEARS THE AUDIBLE CLICK WHEN ATTACHING THE INFUSION HEADSET TO THE INFUSION SET TUBING. PATIENT STATED SHE CAN SEE WETNESS ON THE ADHESIVE. PATIENT REPORTED SHE DID NOT SMELL INSULIN. PATIENT STATED THE ELEVATED BLOOD GLUCOSE LEVELS HAVE BEEN GOING ON FOR 5 DAYS, SINCE SHE BEGAN USING NEW INFUSION SETS. PATIENT'S BLOOD GLUCOSE READINGS ARE 200 MG/DL, 300 - 400 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS LOW 100'S MG/DL TO THE LOW 200'S MG/DL. PATIENT REPORTED SHE DISCONNECTED FROM THE INFUSION DEVICE TODAY DUE TO THE LEAK; IS INJECTING INSULIN BY SYRINGE. PATIENT STATED HER BLOOD GLUCOSE LEVEL IS COMING DOWN WHEN SHE INJECTS INSULIN. PATIENT REPORTED SHE BELIEVES HER BLOOD GLUCOSE LEVEL IS ELEVATED DUE TO NOT GETTING INSULIN DUE TO A LEAK SOMEWHERE. PATIENT STATED SHE HAS CHANGED THE INFUSION SET 5 TIMES IN 5 DAYS. ASSISTED PATIENT WITH CORRECTING THE TIME ON THE INFUSION DEVICE. PATIENT REPORTED SHE REMOVED THE INFUSION HEADSET FROM HER BODY AND NOTICED POOLING OF MOISTURE UNDERNEATH THE ADHESIVE WHICH COULD BE INSULIN THAT SHE DID NOT RECEIVE IN HER BODY. PATIENT STATED THE CANNULA IS NOT BENT. PATIENT DOES NOT HAVE A BACKUP INFUSION DEVICE. ON FOLLOW UP CALL ON (B)(6) 2013 PATIENT REPORTED HER BLOOD GLUCOSE LEVEL IS BACK TO NORMAL. PATIENT STATED SHE TRIED A NEW INFUSION SET WITH A DIFFERENT LOT NUMBER AND HER READINGS HAVE BEEN FINE EVER SINCE. PATIENT REPORTED SHE FEELS THE ELEVATED BLOOD GLUCOSE CONCERN MUST HAVE BEEN DUE TO THE LEAKY INFUSION SET. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173812 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA 5016692

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR BLOOD SUGAR METER - FREESTYLE| NOVALOG & HUMALOG