MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported one (1) erroneously elevated cyclosporine a (csa) patient sample result was obtained on a dimension® exl¿ 200 integrated chemistry system.The erroneously elevated patient result was not reported to the physician.The same sample was manually diluted and reprocessed two times on the same dimension® exl¿ 200 integrated chemistry system.Lower results were obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated cyclosporine a (csa) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated cyclosporine a (csa) results obtained on one (1) patient sample on a dimension® exl¿ 200 integrated chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (20-aug-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Quality control (qc) recovered within the customer's acceptable ranges.No reagent nor 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 hsc investigation.Initial mdr 2517506-2024-00176 was filed on 01-july-2024.

• Brand Name: DIMENSION® CYCLOSPORINE FLEX® REAGENT CARTRIDGE
• Common Device Name: CYCLOSPORINE
• 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: 19642732
• Report Number: 2517506-2024-00176
• Device Sequence Number: 7146346
• Product Code: MKW
• UDI-Device Identifier: 00842768025136
• UDI-Public: 00842768025136
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K023065
• 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): 09/06/2024

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: 03/13/2025
• Device Model Number: N/A
• Device Catalogue Number: 10285193
• Device Lot Number: ED5072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male