MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE

Model Number	DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and noted that the standard (std) a solution was replaced on (b)(6) 2020, and quality control (qc) was out on (b)(6) 2020 at 1:30 a.M.The customer replaced the x tubing, sensor, diluent, and sample probe tip.An alignment, condition test, and dilcheck were performed, and no issues were noted.The customer reported that qc was within the laboratory ranges, and the dimension exl instrument is operating as expected.Siemens reviewed the information provided and observed a successful calibration before processing the sample.It was noted that standard a was changed 2 hours before the samples were processed, and qc was in range when the sample was run.Siemens confirmed the sample was centrifuged in an aptio centrifuge for 5 minutes, per the customers' protocol, and ran in a small sample container.Based on the information provided, siemens determined that the sample was centrifuged using statspin and is outside the tube manufacturer's instructions for centrifugation at 1100-1300g for 10 minutes.The cause of a falsely depressed sodium (na) result on a dimension exl instrument is unknown.Siemens concluded that contributing factors such as sample integrity and preanalytical variables could not be ruled out as a potential cause of the event.The instrument is performing according to the specifications.No further evaluation of this device is required.
Event or Problem Description
The customer obtained a discordant, falsely depressed, sodium (na) result on a dimension exl with lm integrated chemistry system and sample transfer module.The falsely depressed result was reported to the physician(s).The customer used the same patient sample to perform repeat testing on an alternate dimension exl instrument.The repeat result was higher, and the customer noted that a corrected report was issued.There are no reports of patient intervention or adverse health consequences due to the falsely depressed sodium (na) result.

• Brand Name: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
• Common Device Name: DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11210868
• Report Number: 2517506-2021-00042
• Device Sequence Number: 3512594
• Product Code: JJE
• UDI-Device Identifier: 00630414593593
• UDI-Public: 00630414593593
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/21/2021

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 INTEGRATED CHEMISTRY SYSTEM AND SAMPLE TRANSFER MODULE
• Device Catalogue Number: 10639337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1