BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2085136 · Received April 15, 2011

    Report

    Report Number
    2183996-2011-01068
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED INSULIN LEAKAGE AND BLEEDING AT HIS INFUSION SITE. THIS OCCURRED WITHIN THE FIRST DAY OF USE OF THE INFUSION NEEDLE. PT WOKE UP AND FOUND HIS SHIRT HAD INSULIN AND BLOOD STAINS. BLOOD GLUCOSE ELEVATED TO THE 300 MG/DL RANGE AS A RESULT, AND NORMAL BLOOD GLUCOSE IS 160-195 MG/DL. PT CHANGED HIS INFUSION NEEDLE AND BOLUSED TO CORRECT HYPERGLYCEMIA. THREE HOURS LATER, BLOOD GLUCOSE WAS BACK IN HIS NORMAL RANGE. THE INFUSION NEEDLE WAS NOT DAMAGED OR BENT. ALLEGED INFUSION SET WAS DISCARDED. PT WAS SENT SAMPLES OF A DIFFERENT TYPE OF INFUSION SET. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL ATTEMPTS WERE MADE TO F/U WITH PT, AND THESE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32496100

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR INSULIN| INSULIN INFUSION DEVICE