MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE

Catalog Number	RF451 SMN 10444889
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an abnormal assay flag with a total prostate specific antigen (tpsa) patient sample result on a dimension® exl¿ with lm integrated chemistry system.The abnormal assay flagged result was reported to the physician and was not questioned.The same sample was reprocessed on the same dimension® exl¿ with lm integrated chemistry system after troubleshooting and a result was obtained without an abnormal assay flag.The reprocessed result without a flag was considered correct and reported to the physician.There is no allegation of unnecessary treatment due to the reporting the abnormal assay flagged result.There are no known reports of patient intervention or adverse health consequences due to the abnormal assay flag with the total prostate specific antigen (tpsa) result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an abnormal assay flagged result that was reported with the total prostate specific antigen (tpsa) assay on a dimension® exl¿ with lm integrated chemistry system and the result was reported.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (17-jul-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges.The customer observed that the chem wash cleaning fluid was insufficient, and the chem wash was replaced.Hsc concluded that the cause of the event was consistent with insufficient chem wash for washing.The issue was resolved with standard troubleshooting.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00183 was filed on 11-jul-2024.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TOTAL PROSTATE SPECIFIC ANTIGEN 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: 19718908
• Report Number: 2517506-2024-00183
• Device Sequence Number: 8033399
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: (01)00842768013874(10)BA4341(17)20241206
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P000021/S002
• 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): 08/06/2024

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: 12/06/2024
• Device Catalogue Number: RF451 SMN 10444889
• Device Lot Number: BA4341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• 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: Unknown