MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE 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	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an erroneously depressed n-terminal pro-brain natriuretic peptide (nt-probnp) result was obtained on a dimension exl with lm integrated chemistry system.Siemens reviewed the system data and found that the quality control (qc) and calibration was acceptable on the day of the event.Clot check data showed slight variations in pressure readings between the initial erroneous and the repeat correct results.A customer service engineer (cse) visited the site, assessed system performance, verified heterogenous module (hm) temperature, mixer voltages, syringe gaps, pump performance, and ran system checks and qc, all of which were acceptable.A product problem was not identified.Based on the available information, the cause of the event is unknown.The customer is operational.The instrument is working according to the specifications.No further evaluation is required.
Event or Problem Description
The customer reported that an erroneously depressed n-terminal pro-brain natriuretic peptide (nt-probnp) result was obtained on a dimension exl with lm integrated chemistry system.The initial result was reported to the physician(s).The sample was repeated thrice on an alternate dimension exl with lm integrated chemistry system and obtained higher results.The repeat results matched the patient¿s clinical history, and one of the results was reported to the physician(s) as correct result.There are no known reports of patient intervention or adverse health consequences due to the erroneous nt-probnp result.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE 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: 22769107
• Report Number: 2517506-2025-00128
• Device Sequence Number: 15749318
• Product Code: NBC
• UDI-Device Identifier: 00842768029912
• UDI-Public: (01)00842768029912(10)EA6065(17)260306
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 03/06/2026
• Device Model Number: N/A
• Device Catalogue Number: 10464526
• Device Lot Number: EA6065
• 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: 07/17/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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