The Administrative Court rejects Draeger Medical System Inc’s appeal

Friday, November 23, 2018

On May 4, 2018, the Swedish Medical Products Agency, MPA, made the decision to prohibit the jaundice meter Dräger JM-105 from the Swedish market until the meter's display of high bilirubin values was modified. Furthermore, the display of all JM-105 products already on the market had to be modified, or withdrawn from the Swedish market before Oct. 31, 2018. The company, Draeger Medical Systems System Inc., appealed against the MPA’s decision. The appeal is now rejected by the Administrative Court.

Dräger JM-105 is a screening device that measures the bilirubin levels in newborn infants in order to identify those with high bilirubin values in need of evaluation and treatment.

The meter was set to display values  exceeding the measurement range 0-340umol/L (0-20.0mg/dL) as "-0-umol/L" (“-0-mg/dL”). The MPA considered that the display of high values posed an unacceptable risk that newborns with high bilirubin values were not identified and treated in time. Delay or absence of treatment can cause permanent brain damage and, in the worst case, death. The MPA is aware of three cases where treatment has been delayed and children suffered brain injury when using the Dräger JM-105.

Background

  • On May 4, 2018, the MPA decided on a market ban for JM-105 until the product was modified. In addition, all meters already on the Swedish market would be modified by 30 October this year and otherwise canceled.
  • On 25 May 2018, the company filed an appeal against the decision of the Authority, requesting, first of all, the decision to be repealed and, secondly, that the deadline for taking the measures would be extended until 31 January 2019.
  • On August 8, 2018, the company announced that new products were fitted with a modified display. These products are therefore not covered by the market ban, but may be sold on the Swedish market.
  • On November 2 this year, the company announced that more than 80% of the meters on the Swedish market had been modified, and that remaining customers were informed and had a replacement meter to use in the meantime. The exception is a hospital that has been removed whose 4 meters could not be located.
  • On 19 November 2018, the administrative authority in Uppsala decided to reject the appeal in its entirety.

    The judgment states, inter alia, that the decision was considered proportionate in view of the purpose of the measure and that minor intervention measures were insufficient given the risks of non-treatment. A revocation / modification of the products concerned was considered possible within the stipulated time. Administrative law assessed that patient safety reasons are in favor of prolonging the time, as misunderstandings are likely to happen with serious consequences as a consequence.
 

Please note the news item’s date of publishing. The Swedish Medical Products Agency does not update news.

 

Contact us

  • Karin Westermark, Swedish Medical Products Agency
    Phone: +46 (0)18 - 17 82 37
 

Related information

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information