MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL

Model Number	DIMENSION EXL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report a falsely depressed albumin (alb) result was obtained on a patient sample on a dimension exl instrument.The quality control was acceptable on the day of the event.On (b)(6) 2023, the customer replaced the sample probe and reagent 1 (r1) probe.A siemens customer service engineer (cse) was dispatched to the customer site.During the visit, the cse replaced the tubing, small sample line syringe, and syringe plunger on reagent 1 (r1) and reagent 2 (r2).The cse changed the ultrasonic on line r1.Next, the cse performed control and mechanical adjustment on the sample, r1 and r2 passage, which recovered acceptably.The customer validated the passage of controls.The cause of the erroneous alb is unknown.The instrument is performing according to the specification.No further evaluation is needed.
Event or Problem Description
A falsely depressed albumin (alb) result was obtained on a patient sample on a dimension exl instrument.The erroneous result was not reported to the physician(s).The sample was repeated on an alternate dimension exl instrument.The repeat result recovered higher than the erroneous result and matched the patient's previous history.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed alb result.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2023-00129 on 30-may-2023.Additional information (06-jun-2023): siemens evaluated the event and concluded that a combination of factors related to sample mix and sample aspiration by the sample syringe, which were addressed by the service actions described in the initial report, potentially contributed to the falsely depressed albumin result.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION EXL
• Common Device Name: DIMENSION EXL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box; 6101; newark NJ 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield WI 06804
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 17022891
• Report Number: 2432235-2023-00129
• Device Sequence Number: 12651090
• Product Code: JJE
• UDI-Device Identifier: 00842768030024
• UDI-Public: 00842768030024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 EXL
• Device Catalogue Number: 10472176
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male