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 02/05/2024

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 three patient samples on the dimension exl with lm instrument.Quality control (qc) was in range on the day of testing.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse replaced both solenoids, flush pump, integrated multisensor technology (imt) port valve, tower assembly, and sample cable conduit.Then, the cse verified the tubing¿s integrity and replaced any necessary tubing, realigned the sampler to the port valve, reprimed the imt system, successfully calibrated the instrument, checked the pump rate, and ran patient samples and a precision study, which recovered acceptably.The cause of the event is related to the instrument and normal troubleshooting resolved the issue.The customer indicated that the issue initiated on (b)(6) 2024 through (b)(6) 2024.However, the customer only provided examples from (b)(6) 2024.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Falsely depressed sodium (na) results were obtained on three patient samples on the dimension exl with lm instrument.The erroneous results were not reported to the physician(s).The samples were repeated on the same instrument and an alternate dimension exl instrument.The repeat results from the alternate instrument recovered higher than the erroneous results and correlated with patients¿ diagnosis.The repeat results from the alternate instrument were considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed na results.

• 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.; 101 silvermine road; registration #: 1226181; brookfield CT 06804
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18822551
• MDR Text Key: 337739990
• Report Number: 2517506-2024-00087
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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