Events

Field Safety Notices about Dimension® clinical chemistry system

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Healthcare Diagnostics Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has determined that dimension® creatinine (crea) may produce depressed results up to 12.7% (or approximately 0.2 mg/dl [18 µmol/l]) for a creatinine result at 1.5 mg/dl [133 µmol/l] when hemolysis exceeds 300 mg/dl [0.19 mmol/l] of hemoglobin. it is important to note that percent hemoglobin interference with dimension® crea is dependent on the creatinine concentration; at a creatinine concentration of 5.0 mg/dl [442 µmol/l], hemoglobin interference at concentrations up to a 1000 mg/dl [0.62 mmol/l] is < 10%. alternately, with an approximate bias of 0.2 mg/dl([18 µmol/l]), the percent hemoglobin interference may be higher at low creatinine concentrations (< 0.8 mg/dl [< 71 µmol/l]). .

Device

Dimension® clinical chemistry system

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS