MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE

Catalog Number	K1023 SMN 10445160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated calcium (ca) result on a patient sample on a dimension vista 500 intelligent lab system.The initial result was not reported to the physician as it failed the delta check but was considered correct.The same sample was reprocessed on the original dimension vista 500 intelligent lab system, and a higher result was obtained, which was considered erroneous and not reported to the physician.Then, the same sample was reprocessed thrice on the original dimension vista 500 intelligent lab system, and lower results compared to the erroneous result were obtained, which matched the patient¿s clinical picture.A result of 8.4 mg/dl was reported to the physician as a correct result.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated calcium (ca) result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated calcium (ca) result obtained on a patient sample on a dimension vista 500 intelligent lab system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.Calibration and quality control (qc) recovery was within the customer¿s expected ranges, and no issues were observed with other patient samples indicating that the ca assay was performing acceptably.Instrument issues were ruled out based on acceptable calibration, review of the instrument data files, and acceptable precision study.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CALCIUM 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20640321
• Report Number: 2517506-2024-00283
• Device Sequence Number: 7488590
• Product Code: CIC
• UDI-Device Identifier: 00842768015618
• UDI-Public: (01)00842768015618(10)24127BA(17)250506
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K061792
• 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): 11/08/2024

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: 05/06/2025
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 24127BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/08/2024
• 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