MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JAUNDICE METER JM- 105; JAUNDICE METER/BILIRUBINOMETER

Model Number MU20105

Device Problem Non Reproducible Results (4029)

Patient Problem Jaundice (2187)

Event Date 06/16/2023

Event Type  Death  

Manufacturer Narrative

As reported by the user, the device in question had a sticker attached identifying that the flashing "-0-" means the measurement is out of range.This sticker was part of a device safety notice/recall issued by draeger (see attached jm-105 usa and ous [outside united states] notifications).The tsb was a field safety corrective action (fsca) where information was provided to users outlining the meaning of the flashing "-0-" reading.In addition, a sticker was provided to be attached to the device to remind users of the "-0-" meaning, tsb 3 was released in march 2018.In alignment with the flashing "-0-" out of range reading, draeger¿s jm105 instructions for use (ifu) also contained the meaning of the flashing "-0-" reading.From draeger's jm-105 jaundice meter ifu, page 49 and 51, measuring: if -0- blinks in a measured value field, the measured value is outside the measurement range (>20.0 mg/dl/>340 mol/l).In november 2018, draeger issued a supplemental technical service bulletin (tsb 5, see attached jm-105 sw update usa and ous notifications) which provided all users with upgraded software, free of charge, to change the indication for an out of range reading to ¿>340" ¿mol/l or ¿>20" mg/dl (depending on the selected units of measure).The units of measure is selected by the users in accordance with the updated instructions for use, which was also released.From draeger¿s ifu for the jm105 jaundice meter, software 1.20, page 57 and 59, measuring: if >20 or >340 blinks in a measured value field, the measured value is outside the measurement range (>20.0 mg/dl/>340 mol/l).Based on draeger¿s investigation of this event, we have been able to confirm that this specific device was not upgraded with the newer software (tsb 5 was not implemented).The device service history indicates that the site was contacted 3 times regarding the tsb 5 field action and draeger had not received a response.As the hospital has indicated that a sticker was attached to the device, we can confirm that tsb 3 was implemented for the device in question.H3 other text : see h10.

Event Description

The following was reported: "newborn young that appear yellow.Was measured with the equipment that is reported here several times as showing 0 in the display.This is misinterpreted as if the value is low and may have contributed to the child getting worse and dying during transfer to another hospital.The death has been reported immediately to the norwegian health authority.This message only applies to the equipment.In the event analysis, it is found that the device shows zero, when the values are above the measurable value range.The manufacturer has pasted a small note on the device warning of this, but the note is almost too small to be read.The undersigned cannot see that this is notified in the product information available online.It is hereby notified that it is easy to misinterpret the display on a device that is in use in norwegian maternity wards.".

Manufacturer Narrative

It was reported that "newborn young that appear yellow.Was measured with the equipment that is reported here several times as showing 0 in the display.This is misinterpreted as if the value is low and may have contributed to the child getting worse and dying during transfer to another hospital.The death has been reported immediately to the norwegian health authority.This message only applies to the equipment.In the event analysis, it is found that the device shows zero, when the values are above the measurable value range.The manufacturer has pasted a small note on the device warning of this, but the note is almost too small to be read.The undersigned cannot see that this is notified in the product information available online.It is hereby notified that it is easy to misinterpret the display on a device that is in use in norwegian maternity wards." as reported by the user, the device in question had a sticker attached identifying that the flashing "-0-" means the measurement is out of range.This sticker was part of a device safety notice/recall issued by draeger.The tsb was a field safety corrective action (fsca) where information was provided to users outlining the meaning of the flashing "-0-" reading.In addition, a sticker was provided to be attached to the device to remind users of the "-0-" meaning, tsb 3 was released in march 2018.In alignment with the flashing "-0-" out of range reading, draeger¿s jm105 instructions for use (ifu) also contained the meaning of the flashing "-0-" reading.From draeger's jm-105 jaundice meter ifu, page 49 and 51, measuring: if -0- blinks in a measured value field, the measured value is outside the measurement range (>20.0 mg/dl/ >340 mol/l).In november 2018, draeger issued a supplemental technical service bulletin which provided all users with upgraded software, free of charge, to change the indication for an out of range reading to ¿>340" mol/l or >20" mg/dl (depending on the selected units of measure).The units of measure is selected by the users in accordance with the updated instructions for use, which was also released.From draeger¿s ifu for the jm105 jaundice meter, software 1.20, page 57 and 59, measuring: if >20 or >340 blinks in a measured value field, the measured value is outside the measurement range (>20.0 mg/dl/ >340 mol/l).Based on draeger¿s investigation of this event, we have been able to confirm that this specific device was not upgraded with the newer software (tsb 5 was not implemented).The device service history indicates that the site was contacted 3 times regarding the tsb 5 field action and draeger had not received a response.As the hospital has indicated that a sticker was attached to the device, we can confirm that tsb 3 was implemented for the device in question.On 4aug24 draeger requested from the hospital that the serial number (b)(6) to be immediately taken out of service and shipped to dräger in oslo.The device was shipped on 15aug24, modified, tested, and returned to customer, however; it was unable to be confirmed if the software had been updated.The device developed a battery fault 19oct24 rendering it unusable and sent back in for repair.The customer was provided with a loaner unit, the device was shipped for repair, and again returned to the customer.As confirmed 25jan24 from the sales manager hospital, the customer has received the unit back after repair.It is working correctly, the firmware has been updated, and the loaner unit has been returned to dräger.H3 other text : see h10.

Event Description

The following was reported: "newborn young that appear yellow.Was measured with the equipment that is reported here several times as showing 0 in the display.This is misinterpreted as if the value is low and may have contributed to the child getting worse and dying during transfer to another hospital.The death has been reported immediately to the norwegian health authority.This message only applies to the equipment.In the event analysis, it is found that the device shows zero, when the values are above the measurable value range.The manufacturer has pasted a small note on the device warning of this, but the note is almost too small to be read.The undersigned cannot see that this is notified in the product information available online.It is hereby notified that it is easy to misinterpret the display on a device that is in use in norwegian maternity wards.".

• Brand Name: JAUNDICE METER JM- 105
• Type of Device: JAUNDICE METER/BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 17277772
• MDR Text Key: 318565895
• Report Number: 2510954-2023-00009
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• PMA/PMN Number: K133175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White