MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JAUNDICE - JM105; JAUNDICE METER/BILIRUBINOMETER

Catalog Number	MU20105
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Jaundice (2187)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported that the jaundice meter, jm105, was one month overdue for calibration.The customer noticed that the meter was giving low readings.When the patient's serum bilirubin (sbr) was 300, the meter gave a reading of 90.After noticing the meter gave multiple low readings, the customer checked the meter and realized it needed calibration.The device was taken out of clinical use and sent to draeger for calibration.It was stated that the customer always kept the meter on the docking station and the nurse checked the device's charge once a day.
Additional Manufacturer Narrative
A complaint was received regarding the jm105 where the customer reported a difference in the tcb readings from the meter when compared to the total serum bilirubin (tsb).No adverse patient impact was reported.The customer only provided one reading (sbr is 300 and on tcb monitor it shows 90) which when converted to a tcb meter reading of 5.22 mg/dl and tsb/blood reading of 17.4 mg/dl, would indicate a low reading outside of the standard 1.5 acceptable deviation defined by drager.Additional information and data were requested however, on (b)(6)2024 it was confirmed that the customer was not willing to provide any further data.A drager engineer repaired the device and according to service report order (b)(4), the device was displaying the "time for periodic calib" message and it was again stated that the customer declined to answer follow up questions.A new battery was installed in the device before the engineer performed the recalibration and sent the unit back to the customer.The calibration certificate lists the date of the last calibration as (b)(6)2023, which was nearly 14 months prior to the date of event listed in the complaint ((b)(6)2024).The instructions for use confirms that when the device is due for calibration, the "time for periodic calib" message will appear on the meter screen each time it is turned on.The instructions for use also informs the user that initial calibration for the jm105 is valid for one year, that recalibration is recommended every 12 months and that the jm105 should be periodically compared to serum bilirubin results for quality control purposes.
Event or Problem Description
It was reported that the jaundice meter, jm105, was one month overdue for calibration.The customer noticed that the meter was giving low readings.For example, when the patient's serum bilirubin (sbr) was 300, the meter would give a reading of 90.The low readings were found after it was used on a few patients, and it was at that point that the customer checked the meter and realized it needed calibration.The device was taken out of clinical use and sent to draeger for calibration.It was stated that the customer always kept the meter on the docking station and the nurse checked the device's charge once a day.

• Brand Name: JAUNDICE - JM105
• Common Device Name: 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784090504
• MDR Report Key: 20483018
• Report Number: 2510954-2024-00046
• Device Sequence Number: 4174579
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)220923(93)MU20105-24
• Combination Product (Y/N): N
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MU20105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown