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

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	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information (18-jan-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the instrument data files, and the information provided by the customer.Quality control (qc) recovered within the customer¿s acceptable ranges.Standard troubleshooting actions were performed on the analyzer.No reagent or instrument issues were identified.The cause of the event is unknown.A potential product issue was not identified.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 2517506-2024-00311 was filed on 26-dec-2024.
Event or Problem Description
The customer reported (1) one erroneously depressed human chorionic gonadotropin (hcg) patient sample result was obtained on a dimension exl 200 integrated chemistry system.It is unknown if the result was reported to the physician.The same sample was reprocessed with a dilution on the same dimension exl 200 integrated chemistry system.A higher result was obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously 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 (1) one erroneously depressed human chorionic gonadotropin (hcg) patient sample result obtained on a dimension exl 200 integrated chemistry system.Siemens is investigating the event.

• Brand Name: DIMENSION HUMAN CHORIONIC GONADOTROPIN FLEX REAGENT CARTRIDGE
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN (HCG)
• 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: 21020592
• Report Number: 2517506-2024-00311
• Device Sequence Number: 9180726
• Product Code: DHA
• UDI-Device Identifier: 00842768013850
• UDI-Public: (01)00842768013850(10)FA5135(17)250515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 01/29/2025

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: 05/15/2025
• Device Model Number: N/A
• Device Catalogue Number: 10444913
• Device Lot Number: FA5135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/18/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: Female