Events

Alerta De Seguridad para Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Beckman Coulter.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2018-08-29
  • Fecha de publicación del evento
    2018-08-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180829b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: beckman coulter lipase, uric acid, hdl-cholesterol, enzymatic creatinine assays medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its following devices: reference: lipase osr6x30; uric acid osr6x98; hdl-cholesterol osr6x87; enzymatic creatinine osr6x204 lot number: all lots the manufacturer informed that napqi (n-acetyl p benzoquinone imine), a metabolite of paracetamol, causes negative interference with enzymatic creatinine osr6x204, hdl- cholesterol osr6x87, lipase osr6x30 and uric acid osr6x98 assays, at levels present in the serum/plasma of overdose patients. napqi in toxic concentrations may potentially lead to erroneously low results for enzymatic creatinine, hdl cholesterol, lipase and uric acid. the risk to patient safety of this event has been determined as remote for enzymatic creatinine and highly unlikely for the remaining assays. paracetamol itself does not interfere with the assays. according to the manufacturer, no action is required by the laboratory. laboratories should be aware that there is a remote probability that napqi in toxic concentrations may potentially lead to erroneously low results for lipase, uric acid, hdl-cholesterol and enzymatic creatinine. the following statement will be added to the interfering substances section of the lipase, uric acid, hdl-cholesterol and enzymatic creatinine ifus (blosr6x30, blosr6x98, blosr6x87 and blosr6x204, respectively: "n-acetyl-p-benzoquillone imine (metabolite of paracetamol) will generate erroneously low results in samples for patients that have taken toxic doses of paracetamol. " according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 august 2018.

Device

Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter