BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3842609 · Received June 2, 2014

    Report

    Report Number
    1823260-2014-03900
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER WAS HOSPITALIZED WITH HYPERGLYCEMIA, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. HER BLOOD GLUCOSE ELEVATED TO 500 MG/DL, AND SHE WAS UNABLE TO LOWER IT BY CHANGING THE ACCESSORIES. SHE WAS DISCHARGED FROM THE HOSPITAL WHEN HER BLOOD GLUCOSE DECREASED TO 188 MG/DL, AND SHE IS NOW DELIVERING INSULIN VIA PEN. THE ALLEGED PRODUCTS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320859 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization