BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3112456 · Received May 14, 2013

    Report

    Report Number
    2183996-2013-00857
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 8, 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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT DESCRIBING A BROKEN/CRACKED LUER CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. RESULT THE USED RETURNED TRANSFER SET WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TRANSFER SET WAS LEAKY AT THE LUER/TRANSFER CONNECTION. THE STATED DAMAGES ARE CAUSED BY A TOO HIGH EFFORT (KINKING/STRETCHING) BY THE USER. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2013 DIABETES EDUCATOR REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL. DIABETES EDUCATOR STATED THERE IS INSULIN LEAKING AT THE LUER LOCK. DIABETES EDUCATOR REPORTED THE LUER LOCK IS NOT CRACKED. DIABETES EDUCATOR STATED THE LEAK IS TAKING PLACE WHERE THE INFUSION SET TUBING CONNECTS TO THE LUER LOCK. DIABETES EDUCATOR REPORTED THAT IT DOES NOT APPEAR THAT THE INFUSION SET TUBING HAS COME DISCONNECTED FROM THE LUER LOCK. PATIENT REPORTED HE FACED A READING OF 590 MG/DL ON (B)(6) 2013; HE BOLUSED FOR THAT. PATIENT STATED THIS MORNING AT 6:40 AM HE FACED A BLOOD GLUCOSE READING OF 403 MG/DL; HE BOLUSED. PATIENT REPORTED THAT AT 9:45 AM, HIS READING WAS 478 MG/DL;HE BOLUSED THEN. PATIENT STATED AT 10ISH HE HAD NO ENERGY AND BLURRY VISION; TOOK A KETONE TEST AND WAS SPILLING KETONES. PATIENT REPORTED HE CALLED THE DOCTOR AND WAS ADVISED TO GO TO THE ER WHERE HE WAS ADMITTED TO THE HOSPITAL AND IS CURRENTLY IN THE ICU. PATIENT STATED HE WAS DIAGNOSED WITH DKA AND IS ON AN IV INSULIN DRIP. PATIENT REPORTED HIS BLOOD GLUCOSE LEVEL IS DECREASING NOW. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS 75-160 MG/DL. ON FOLLOW UP CALL ON (B)(6) 2013 PATIENT REPORTED HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. PATIENT STATED THE LEAK OCCURRED WHILE THE INFUSION DEVICE WAS IN RUN MODE. PATIENT REPORTED HIS ELEVATED BLOOD GLUCOSE READING WAS DUE TO THE LUER LOCK LEAKING. PATIENT STATED HE WAS TAKEN OFF OF THE INSULIN IV DRIP AND WENT BACK ON THE INFUSION DEVICE USING NEW INFUSION TUBING; HIS BLOOD GLUCOSE REMAINED IN THE TARGET RANGE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211993 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR Hospitalization| O| R NOVALOG| BLOOD PRESSURE MED, NOT SURE N| GENERIC ALLEGRA| LENICIPRIL