MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; 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	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Five (5) discordant falsely depressed sodium (na) patient sample results were obtained on a dimension exl w/lm stm system.The discordant results were reported to the physician(s).The same samples were reprocessed on the same dimension system and higher results, considered correct, were obtained.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed sodium results.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding five (5) falsely depressed sodium (na) patient sample results obtained on a dimension® exl¿ with lm integrated chemistry system and sample transfer module.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (12-jul-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.The customer performed maintenance that was part of normal troubleshooting.The customer adjusted the dilution factor and processed quality control which was within laboratory acceptance range after maintenance.Repeat of the same samples yielded expected results.A potential product problem was not identified with the sodium assay or the dimension exl with lm system and sample transfer module.The cause of the event is unknown.The instrument is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2022-00178 was filed 11-jul-2022.

• Brand Name: DIMENSION®
• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC. BROOKFIELD; registration number 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 14976451
• Report Number: 2517506-2022-00178
• Device Sequence Number: 5689853
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: SMN 10639337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown