MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneous calcium (ca) results were obtained on two patient samples on a dimension vista 500 instrument.The customer calibrated the ca assay.Siemens reviewed the instrument data and determined that quality control (qc) recovered out of range with abnormal assay flags and calibration was acceptable with abnormal assay flags.Further, siemens reviewed the result calculation data and observed errors, which indicates a mixing issue.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse entered diagnostics mode, ran service methods and sample 1 (s1) mix test.Further, the cse replaced the s1 mixer and belt, ran a system quick check, which passed, and ran calibration and qc, which recovered acceptably.Siemens evaluated the event and determined that improper sample mixing potentially contributed to the erroneous ca results.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that erroneous calcium (ca) results were obtained on two patient samples on a dimension vista 500 instrument.The initial results were not reported to the physician(s).For sample identifier (b)(6) the sample was repeated twice on the original instrument.The repeat results recovered lower than the initial result and were considered erroneous.The repeat results were not reported to the physician(s).For both sample identifiers, the customer declined to provide further information on the patient sample results data, including the correct results obtained.Therefore, the correct results reported for the two patient samples are unknown.There are no known reports of patient intervention or adverse health consequences due to the erroneous ca results.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20795055
• Report Number: 2517506-2024-00293
• Device Sequence Number: 6989536
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 11/27/2024

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 Model Number: DIMENSION VISTA 500
• Device Catalogue Number: 10284473
• 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: 11/04/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown