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

Model Number MU20105

Device Problem Low Readings (2460)

Patient Problem Jaundice (2187)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that the customer has consistently noted a difference in a jm-105 jaundice meters readings of 6 to 7mg/dl lower from serum on two different laboratory devices.No adverse patient impact was reported.

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Manufacturer Narrative

The customer provided patient tcb and tsb reading comparison data used to determine the differences in tcb and tsb readings for analysis.However, as the data provided does not include the age of the babies or the time that the blood was drawn, it cannot be analyzed.The customer was asked to repeat the measurements using the provided data collection sheet (which includes fields for the data needed for comparison analysis).No further information was provided by the customer.As per the instructions for use, the age population for the device to be used on is >= 35 weeks gestation up 14 days old.Additionally, the time of the blood test to compare to the meter reading must be documented and taken within an hour of the meter reading for a comparison to be made.Therefore, the reported reading differences could not be verified.The involved meter was return to draeger for investigation and has been evaluated by draeger engineering.The meter was tested on the light checker and the measurements were within specification.Therefore, the root cause of the reported issue cannot be determined.Though no malfunction was identified, the meter was recalibrated for customer satisfaction and returned to the customer through the draeger medical repair center.

Event Description

It was reported that the customer has consistently noted a difference in a jm-105 jaundice meters readings of 6 to 7mg/dl lower from serum on two different laboratory devices.No adverse patient impact was reported.

• Brand Name: JM-105 JAUNDICE METER
• 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: 16935838
• MDR Text Key: 315321424
• Report Number: 2510954-2023-00005
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)230102(93)MU20105-24
• Combination Product (y/n): N
• PMA/PMN Number: K133175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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
• Device Operator: Health Professional
• Device Model Number: MU20105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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