StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Publicado el 1 de enero de 2025 · Inicio del retiro: 20 de noviembre de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Nova Biomedical Corporation
- Distribuidor
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
- Lote
- Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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