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

Model Number	DIMENSION EXL WITH LM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that a discordant, falsely elevated sodium (na) result was obtained on a patient sample on a dimension exl with lm instrument.As per siemens' instructions, the customer prime standard a and standard b, adjusted the pump rate, replaced the x tubing, and ran calibration and quality controls (qc), which recovered within range.A precision study was performed and all results were acceptable.Siemens further investigated the issue and determined that there were successful calibrations before the sample was processed and there were no instrument errors.Qc was also run before and after the sample was run and all the results were within range.Qc was in range and no issues were noted with other patient samples, indicating that the instrument and reagents were performing acceptably.Repeat of the same sample yielded expected results.Contributing factors such as sample integrity and preanalytical variables potentially contributed to the discordant, falsely elevated na result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated sodium (na) result was obtained on a patient sample on a dimension exl with lm instrument.The falsely elevated result was not reported to the physician(s).The sample was repeated on two instruments resulting lower.The customer only provided one repeat result and indicated that the repeat result of 133 mmol/l was reported to the physician(s) as the correct result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated na result.

• Brand Name: DIMENSION EXL WITH LM
• Common Device Name: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11014094
• Report Number: 2517506-2020-00375
• Device Sequence Number: 4495858
• Product Code: JJE
• UDI-Device Identifier: 00630414593593
• UDI-Public: 00630414593593
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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 Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10639337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1