BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3082641 · Received April 29, 2013

    Report

    Report Number
    2183996-2013-00754
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    July 22, 2013
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE MATERIAL MEETS PRODUCT SPECIFICATIONS. A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED UNUSED INFUSION SET. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD FOR # (B)(4) WAS VERIFIED AND NO DEVIATION WAS FOUND.

    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 THE INFUSION SET IS LEAKING INSULIN AROUND THE ADHESIVE. PATIENT STATED THIS HAS CAUSED ELEVATED BLOOD GLUCOSE LEVELS. PATIENT REPORTED THIS IS THE 2ND WEEK IN A ROW THAT THIS HAS OCCURRED. PATIENT STATED SHE FIRST NOTICED IT LAST WEEK ALSO. PATIENT REPORTED HER BLOOD GLUCOSE READINGS STARTED AT 388 MG/DL AND THEN 377 MG/DL; PATIENT GAVE HERSELF 6 UNITS OF INSULIN. PATIENT STATED 2 HOURS LATER SHE TESTED AGAIN AND HER BLOOD GLUCOSE LEVEL WAS 374 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS AROUND 120-170 MG/DL. NO OUTSIDE MEDICAL ATTENTION HAS BEEN NECESSARY. PATIENT REPORTED SHE HAS HAD NO SYMPTOMS OF ELEVATED READINGS. PATIENT STATED WHEN SHE RECEIVED THE READING OF 374 MG/DL; SHE LOOKED DOWN AND SAW INSULIN ALL IN THE INFUSION SITE UNDER THE ADHESIVE. PATIENT REPORTED SHE CAME HOME AND CHANGED IT. PATIENT STATED THERE WERE NO BENDS, NICKS, OR TEARS IN THE CANNULA OR ADHESIVE THAT SHE COULD SEE. PATIENT REPORTED THERE WAS BLOOD AND INSULIN UNDER THE ADHESIVE AND THERE IS A SLIGHT LUMP OF INSULIN WHICH MAY BE POOLING. PATIENT STATED THIS HAS OCCURRED AT LEAST 5 OR MORE TIMES WITH THIS BOX OF INFUSION SETS SO SHE DOESN'T KNOW IF IT'S RELATED TO SCAR TISSUE OR THE INFUSION SET IS LEAKING. PATIENT TESTED DURING THE CALL WITH A READING OF 171 MG/DL, WHICH IS ALMOST AT HER NORMAL RANGE. 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 SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183779 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL A/S NA 223542

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR INSULIN