MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR; ELECTRODE, ION SPECIFIC, SODIUM

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	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium (na) patient result obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported one (1) erroneously depressed sodium (na) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The erroneously depressed sodium result was reported to the physician(s) and as a result, it was indicated the patient was hospitalized due to a "concern regarding over-correction due to a >6 mmol/l delta check" and "risk for demyelination" and was treated.The patient was administered 1 liter of normal saline and started ddavp-d5w.Three (3) subsequent sample draws from the same patient were performed and processed on the original dimension® exl¿ 200 integrated chemistry system.Higher sodium results were obtained for all three samples, which were considered correct and reported.An additional sample was drawn from the same patient and processed on an alternate dimension® exl¿ with lm integrated chemistry system.A higher sodium result was obtained and considered correct.The original sample that obtained an erroneous sodium result, was retested on the original dimension® exl¿ 200 integrated chemistry system the following day and a higher result was obtained, considered correct, and reported as the amended result.There are no known adverse health consequences due to the erroneously depressed sodium result.
Additional Manufacturer Narrative
Additional information (08-oct-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the available instrument data.Quality control (qc) recovered within the customer's acceptable ranges.No reagent or instrument issues were identified.The cause of the event is unknown.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr was filed on 03-oct-2024.

• Brand Name: DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• 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: 20358673
• Report Number: 2517506-2024-00262
• Device Sequence Number: 7208948
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)4DD811(17)241026
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/14/2024

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: 10/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 10445058
• Device Lot Number: 4DD811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 04/29/2024
• 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 Age: 68 YR
• Patient Sex: Female