BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 2170894 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01835
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT SHE HAS EXPERIENCED INSULIN LEAKAGE AT HER INFUSION SITES SINCE STARTING A NEW TYPE OF INFUSION SET. PATIENT WILL NOTICE HER SHIRT AND THE INFUSION SET ADHESIVE ARE WET. INFUSION HEADSETS ARE INSERTED AT A 45 DEGREE ANGLE, AND SITES ARE ROTATED WELL. FOLLOW-UP WAS PROVIDED ON (B)(6) 2011, AND PATIENT REPORTED THE INFUSION SET LEAKED INSULIN AGAIN ON (B)(6) 2011. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THREE ADDITIONAL ATTEMPTS WERE MADE TO REACH PATIENT, AND THESE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 644225

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN INFUSION DEVICE| INSULIN