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	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed sodium (na) results on three (3) patient samples 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 erroneously depressed sodium (na) results on three (3) patient samples on a dimension exl with lm system.The erroneously depressed patient results were not reported to physician(s).The same samples were reprocessed on the same dimension exl with lm system.The reprocessed results recovered higher and were reported as correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) results.
Additional Manufacturer Narrative
Additional information (05-aug-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.Calibration and quality control (qc) recovery was within the customer¿s expected ranges, indicating that the sodium (na) assay was performing acceptably.Hsc concluded that the cause of the event was consistent with dilution check correction factor not in normal range.The issue was resolved by resetting the correction factor and running a fresh new bottle of dilution check solution.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2517506-2024-00201 was filed on 26-jul-2024.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® QUIKLYTE® INTEGRATED MULTISENSOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; 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: 19836666
• Report Number: 2517506-2024-00201
• Device Sequence Number: 18096820
• Product Code: JGS
• UDI-Device Identifier: 00842768014291
• UDI-Public: (01)00842768014291(10)4AD803(17)20240720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 07/20/2024
• Device Model Number: N/A
• Device Catalogue Number: S600 SMN 10445058
• Device Lot Number: 4AD803
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2024
• 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