MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM

Model Number	DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed potassium (k) patient sample result obtained on a dimension exl with lm system.Siemens healthcare diagnostics headquarters support center (hsc) reviewed the information provided by the customer and the instrument data logs.A siemens customer service engineer (cse) was dispatched to the customer's site and performed service tasks for events of this nature.System verification indicated acceptable performance after the service visit.Repeat of the same sample yielded the expected result.The cause of the event is unknown.The system is fully operational.The device is performing according to specifications.No further evaluation is required.
Event or Problem Description
A discordant falsely depressed potassium (k) patient sample result was obtained on a dimension exl with lm system.The falsely depressed patient result was reported to the physician.The same sample was reprocessed and a higher result was obtained, considered correct and reported.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed potassium (k) result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® EXL¿ WITH LM INTEGRATED CHEMISTRY SYSTEM
• 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: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 15851447
• Report Number: 2517506-2022-00307
• Device Sequence Number: 20097345
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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
• Device Catalogue Number: SMN 10472176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2014
• 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