Jaundice Meters Subject to FDA Class I Recall

Megan Brooks

Disclosures

June 26, 2018

Draeger Medical Systems, Inc, has recalled more than 4500 of the company's jaundice meters because users have misinterpreted display messages, leading to serious adverse events, according to a notice posted on the US Food and Drug Administration (FDA) website.

This class I recall covers two models: JM-103 (a total of 2449 meters), and JM-105 (2063 meters).

The JM-103 jaundice meter displays three blinking dashes (- - -), and the JM-105 meter displays a dash-zero-dash signal (-0-) when the bilirubin level is higher than the maximum level of detection (>340 µmol or 20 mg/dL). Some users have interpreted the two display messages as indicating a "low" or "zero" value instead of a high bilirubin level, which requires immediate medical evaluation, according to the recall notice.

"The out of range display is visible; however, the interpretation of the reading is not intuitive or clear. Uncertainty about the out of range indication on the jaundice meter could cause a delay of treatment in a patient with hyperbilirubinemia. This misuse of display information could increase risk for serious adverse health consequences such as acute and/or chronic brain damage or death," the notice states.

In one case in Sweden and one case in the United Kingdom, the uncertainty about a reading with the JM-105 device may have been a factor in the delay of treatment of a patient with hyperbilirubinemia, Draeger Medical said in a letter to customers.

The company has provided customers with labels that should be applied directly onto the meter to remind the user of the meaning of the blinking dashes (- - -) for the JM-103 model and "-0-" signal for the JM-105 model. For the JM-103, the label has a picture of three blinking dashes (- - -); for the JM-105, the label has a picture of the "-0-" signal. Both labels provide an interpretation of the signals, stating, "Measurement out of range >340µmol/L/20mg/dL."

The recalled meters have product code MQM. The JM-103 has model number MU20606, and the JM-105 has model number MU20105. The JM-103 meters were manufactured from June 2008 to August 2017 and were distributed from July 2008 to September 2017. The JM-105 meters were manufactured from September 2013 to April 2018 and were distributed from October 2013 to April 2018.

Draeger Medical is asking customers to ensure that all JM-105 and JM-103 devices are labeled according to the instructions provided by the firm.

The company says users should be trained in how to use the equipment and that it be ensured that users understand that the device is to be used for screening, not as a stand-alone diagnostic device. The company recommends that a blood test be performed if a bilirubin measurement is higher than the devices' maximum value of 20 mg/dL or 340 µmol.

Customers are also asked to complete and return a customer reply card sent by the firm. Customers with questions about this recall may call 1-800-437-2437 (press 1 at the prompt than 32349) between the hours of 8:00 am and 4:30 pm Eastern Standard Time.

Healthcare providers are encouraged to report problems with these products to MedWatch, the FDA's safety information and adverse event reporting program.

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