BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER

    MDR report key: 2871440 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01910
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, WIFE REQUESTED ASSISTANCE TURNING OFF THE BEEP ON THE INFUSION DEVICE. SHE REPORTED THE PT WAS HOSPITALIZED DUE TO A LOW WHITE BLOOD CELL COUNT AND HAD AN INFECTION AT HIS INFUSION SITE. F/U WAS COMPLETED WITH THE PT ON (B)(6) 2012. HIS INFUSION SITE WAS RED AND IRRITATED AND HE WAS TREATED WITH AN IV OF ANTIBIOTICS. HE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AND DISCHARGED ON (B)(6) 2012. THE ALLEGED INFUSION SET WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 647235

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN