BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2090197 · Received May 6, 2011

    Report

    Report Number
    2183996-2011-01280
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT HE WAS HOSPITALIZED FOR HYPERGLYCEMIA OF "HI" MG/DL DUE TO INSULIN LEAKAGE FROM THE INFUSION SETS. THE INSULIN LEAKED NEAR HIS INFUSION SITE. PATIENT WAS ADMITTED TO THE HOSPITAL FOR 2-3 DAYS DUE TO HYPERGLYCEMIA AND FOR AN INFECTION THAT WAS NOT RELATED TO THE INFUSION DEVICE SYSTEM. NORMAL BLOOD GLUCOSE IS 80-150 MG/DL. THE INFUSION NEEDLE IS USED FOR 1-2 DAYS BEFORE THE LEAK OCCURS, AND THE INFUSION SITES ARE TYPICALLY LOCATED ON THE LEFT SIDE OF HIS ABDOMEN. PATIENT CAN SMELL INSULIN AND FEEL THAT THE INFUSION SET ADHESIVE IS WET. ALLEGED INFUSION SET WAS DISCARDED AFTER USE. PRODUCT WAS REPLACED WITH A DIFFERENT TYPE OF INFUSION SET. SEVERAL ATTEMPTS WERE MADE TO FOLLOW-UP WITH PATIENT, AND THESE ATTEMPTS 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 32496280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN (DATE OF TX: (B)(6)| INSULIN INFUSION DEVICE| (DATE OF TX: APPROX (B)(6))