BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D LINK INFUSION SET

    MDR report key: 2170890 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01898
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, THE ADAPTER/LUER CONNECTION ON THE INFUSION SET IS LEAKY. PT STATED, HE NOTICED THE ISSUE FOR 14 DAYS. PT REPORTED, HE CHANGED TO A NEW INFUSION ADAPTER AND A NEW INFUSION SET, BUT THE ISSUE CONTINUED. PT STATED HIS BLOOD GLUCOSE LEVEL WENT UP TO 500 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 103-106 MG/DL. PT REPORTED HE TOOK CORRECTION VIA THE INFUSION DEVICE AND WAS ABLE TO GET HIS BLOOD GLUCOSE UNDER CONTROL BY HIMSELF. NO FURTHER INFO IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID-D LINK INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 32331160

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR INSULIN INFUSION PUMP| INSULIN