MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION QUIKLYTE INTEGRATED MULTISENSOR

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding the erroneously depressed sodium (na) patient sample results obtained on a dimension exl with lm system.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously depressed sodium (na) patient sample result on a dimension exl with lm system.The same sample was reprocessed on the original dimension exl with lm system and a lower result was obtained and considered erroneous.The erroneously depressed results were reported to the physician(s), and the results were not questioned.The sample was reprocessed on an alternate dimension exl 200 system and the result obtained was higher, matched patient history and was considered correct.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) patient results.
Additional Manufacturer Narrative
Additional information (10-may-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Hsc observed that calibration was within the customer's acceptable ranges.The customer stated that quality control (qc) was low, and an erroneously depressed patient sample result was observed.The customer replaced the standard a two times, the standard b, and the diluent.The customer also performed a system clean and conditioning with a new sensor of the same lot and processed a dilution check, which was within the acceptable range.The customer then processed qc and the qc recovered within the expected range.Several patient samples were processed on both the original system and an alternate system, and the results matched between the systems.No erroneous results were reported by the customer after these standard troubleshooting and maintenance actions were performed on the system.The cause of the event is unknown.The customer 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 2517506-2024-00143 was filed on 08-may-2024.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION QUIKLYTE INTEGRATED MULTISENSOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19271446
• Report Number: 2517506-2024-00143
• Device Sequence Number: 6948912
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: 00842768014291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112999
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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 Expiration Date: 07/06/2024
• Device Model Number: N/A
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4AD802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown