Events

Field Safety Notices about Dimension Lipase

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
    2017-12-22
  • 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 received customer complaints regarding a positive bias in qc results and patient samples when using dimension® lipl flex® lot fb8109. siemens internal investigation has confirmed the positive bias with lipl lot fb8109 when compared to other dimension lipl lots. lot fb8109 is not meeting siemens internal specifications for lot-to-lot limits. the investigation compared lot fb8109 with control lot gb8141 (historical performance representative dimension lipase lot). the lot comparison between dimension lipl lot fb8109 and lot gb8141, when using patient samples, demonstrated an average positive bias of 15%. the range of positive bias of 11% (1028 u/l using lot gb8141, as reference lot vs 1141 u/l using lot fb8109) to 22% (94 u/l using lot gb8141 as reference lot vs 114 u/l using lot fb8109). see graph 1 for lot comparison data. .

Device

Dimension Lipase

Manufacturer

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