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

Catalog Number	10444929
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that the erroneously depressed vancomycin (vanc) results were obtained on four patient samples on a dimension exl with lm integrated chemistry system.Siemens reviewed the instrument data, and the information provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges.However, quality control (qc) recovery immediately after the discordant patient samples run was low.Following this, the customer loaded a new vanc flex reagent and reran the qc, which recovered within the acceptable laboratory range.The customer ran survey samples and performed a precision study which recovered acceptably.Based on the available information, the cause of the event is unknown.The customer is operational.The system is performing according to specifications.No further evaluation is required.
Event or Problem Description
The customer reported that erroneously depressed vancomycin (vanc) results were obtained on four patient samples on a dimension exl with lm integrated chemistry system.The erroneous results were reported to the physician(s) and were questioned.The samples were repeated on same dimension exl with lm integrated chemistry system.The repeat results recovered higher and were considered correct.The repeat results were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the depressed vanc results.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24543172
• Report Number: 2517506-2026-00049
• Device Sequence Number: 15751559
• Product Code: LEH
• UDI-Device Identifier: 00842768005763
• UDI-Public: (01)00842768005763(10)EB6324(17)261120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130276
• 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): 03/09/2026

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 Catalogue Number: 10444929
• Device Lot Number: EB6324
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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