MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number DIMENSION EXL WITH LM

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely depressed sodium (na) results were obtained on two patient samples on the dimension exl with lm instrument.Siemens also reviewed the instrument files and determined that there were multiple ¿clotted sample probe¿ errors.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced all of the tubing and superconditioned the instrument.Additionally, the cse replaced the integrated multisensor technology (imt) tower and performed a precision study, which recovered acceptably.The cause of the falsely depressed na results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported that falsely depressed sodium (na) results were obtained on two patient samples on the dimension exl with lm instrument.The initial results were reported to the physician(s) and were questioned.The repeat results recovered higher than the initial results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed na results.

Manufacturer Narrative

Siemens filed initial mdr 2517506-2024-00092 on 06-mar-2024.Additional information (22-mar-2024): during a service visit, the customer service engineer (cse) identified a sample handling issue at the customer¿s site.Siemens also noticed that there was an error that indicated a clot in the sample probe.There was no indication of an issue with the integrated multisensor technology (imt) sensor lot.The cause of the falsely depressed sodium results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18852172
• MDR Text Key: 337797113
• Report Number: 2517506-2024-00092
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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