MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® HUMAN CHORIONIC GONADOTROPIN (HCG) FLEX® REAGENT CARTRIDGE

Catalog Number	RF430 SMN 10444913
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely depressed human chorionic gonadotropin (hcg) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The falsely depressed patient result was reported to the physician(s) and was questioned.The same sample was reprocessed on the same dimension® exl¿ 200 integrated chemistry system on (b)(6) 2024.The higher reprocessed result obtained was considered correct and a corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed human chorionic gonadotropin (hcg) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed human chorionic gonadotropin (hcg) patient result obtained on a dimension® exl¿ 200 integrated chemistry system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.Calibration and quality control (qc) recovered within the customer's expected ranges.Hsc observed the aspiration pressure was shifting high which suggests that micro clots were present in the affected patient sample.The cause of the event is consistent with a sample integrity issue.The customer is fully operational.The device is performing according to specifications.No further evaluation is required.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® HUMAN CHORIONIC GONADOTROPIN (HCG) FLEX® REAGENT CARTRIDGE
• 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: 19020722
• Report Number: 2517506-2024-00115
• Device Sequence Number: 12747541
• Product Code: DHA
• UDI-Device Identifier: 00842768013850
• UDI-Public: 00842768013850
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K970387
• 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): 04/02/2024

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: 07/30/2024
• Device Catalogue Number: RF430 SMN 10444913
• Device Lot Number: GC4212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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: Female