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

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained an erroneously depressed vancomycin (vanc) patient result on a dimension vista 500 intelligent lab system.The erroneous patient result was not reported to the physician.The same sample was reprocessed on the original dimension vista 500 intelligent lab system and a higher result was obtained, considered correct and not reported to the physician.The same sample was reprocessed on an alternate dimension vista 500 intelligent lab system and a higher result was obtained, considered correct and reported to the physician.There is no known reports of patient intervention or adverse health consequences due to the erroneously depressed vancomycin (vanc) result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed vancomycin (vanc) patient result obtained on a dimension vista 500 intelligent lab system.Siemens is evaluating the event.
Additional Manufacturer Narrative
Additional information (17-oct-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files, and the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges, and no issues were reported with the other patient samples which ruled out the reagent issues.No instrument errors were observed.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2517506-2024-00241 was filed on 01-oct-2024.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA VANCOMYCIN 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, DE 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20343797
• Report Number: 2517506-2024-00241
• Device Sequence Number: 18193106
• Product Code: LEH
• UDI-Device Identifier: 00842768015533
• UDI-Public: (01)00842768015533(10)24102BA(17)250411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061655
• 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): 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: 04/11/2025
• Device Model Number: N/A
• Device Catalogue Number: K4086 SMN 10445128
• Device Lot Number: 24102BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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