MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION HUMAN CHORIONIC GONADOTROPIN (HCG); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

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	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) to report a discordant depressed human chorionic gonadotropin (hcg) result that was obtained on a patient sample on a dimension exl 200 instrument.Siemens reviewed the data from the dimension exl 200 instrument.Evaluation of the result for sid (b)(6) is not possible as there is no supporting data from the instrument for this sample.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the instrument and no issues were identified.The quality control (qc) from the time of the event was in range.The cause of the falsely depressed hcg result is unknown.A potential product issue was not identified.The device is performing within specifications.
Event or Problem Description
A depressed human chorionic gonadotropin (hcg) result was obtained on a patient sample on a dimension exl 200 instrument.The depressed result was reported to the physician(s), who did not question the result.There was no follow up testing for the patient.The patient was found to be pregnant at a later date (date not provided).The doctor stated when the hcg was run on (b)(6) 2023 the patient's last missed menses was on (b)(6) 2023.It is unknown at this time as to when (date/days after last menstrual period) the patient was diagnosed as pregnant.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed human chorionic gonadotropin (hcg) result.

• Brand Name: DIMENSION HUMAN CHORIONIC GONADOTROPIN (HCG)
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18543915
• Report Number: 2517506-2024-00025
• Device Sequence Number: 8914933
• Product Code: DHA
• UDI-Device Identifier: 00842768013850
• UDI-Public: 00842768013850
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2024

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: 03/02/2024
• Device Model Number: N/A
• Device Catalogue Number: 10444913
• Device Lot Number: FA4062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/19/2024
• Date Device Manufactured: 02/28/2023
• 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 Age: 20 YR
• Patient Sex: Female