Events

Field Safety Notices about RAPIDPoint® 500 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 GmbH.

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
  • Date
    2015-09-07
  • 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
    During the manufacturing process, the sodium high calibrator value was incorrectly assigned for the rapidpoint 500 measurement cartridge serial numbers indicated above, causing a negative bias on both qc and patient samples. the following table indicates the negative bias siemens observed using patient specimens. .

Device

RAPIDPoint® 500 System
  • Model / Serial
    RAPIDPoint 500 Cartridge Serial Numbers Affected 10491449 RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) 2517102517 through 2519000012 See note below 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (400 tests) 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (250 tests) 10844813 RAPIDPoint 500 Measurement Cartridge Lactate (100 tests)
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

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