MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION PHOSPHORUS FLEX REAGENT CARTRIDGE; INORGANIC PHOSPHORUS

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	09/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated phosphorus (phos) result on a dimension exl 200 integrated chemistry system.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained an erroneously elevated phosphorus (phos) result on a dimension exl 200 integrated chemistry system.The erroneously elevated result was reported to the physician and not questioned.The same sample was reprocessed on the original dimension exl 200 integrated chemistry system.A lower 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 elevated phosphorus (phos) result.
Additional Manufacturer Narrative
Additional information (10-feb-2025): siemens service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer.No reagent issues were identified.A siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.A white piece of material was found on the syringe tip on the instrument.No discordant results were reported after the syringe tip was replaced.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2517506-2025-00014 was filed on 27-jan-2025.

• Brand Name: DIMENSION PHOSPHORUS FLEX REAGENT CARTRIDGE
• Common Device Name: INORGANIC PHOSPHORUS
• 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 ; 7372808688
• MDR Report Key: 21242683
• Report Number: 2517506-2025-00014
• Device Sequence Number: 3640589
• Product Code: CEO
• UDI-Device Identifier: 00630414594484
• UDI-Public: (01)00630414594484(10)BA5119(17)250429
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/02/2025

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: 04/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 10720277
• Device Lot Number: BA5119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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: Unknown